Radiology, InterventionalNR-RythmoNCT06507085
Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.
An observational study of Radiology, Interventional and Heart Rhythm Disorders, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Interventional radiology has become a widespread technique used in various fields of medicine to diagnose or treat numerous pathologies. However, the risk of X-rays must be taken into account. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiology, Interventional, Heart Rhythm Disorders
- What is being tested?
- Radio-guided interventions to correct heart rhythm disorders
- Type of treatment
- Surgery or procedure
- How many people
- 4,219 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to 29 Sep 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population: All patients benefitting from a rhythmology procedure to be performed among the procedures defined in the inclusion criteria.
Who may be able to join
- Adult male/female patient (≥ 18 years)
- Body Mass Index (BMI) between 18 and 35 kg/m².
- Patient to benefit from one of the following procedures:
- Placement of single-chamber pacemaker with lead (DELF 007 according to CCAM) Dual-chamber pacemaker insertion with lead (DELF 005 according to CCAM) Multi-site pacemaker placement (DELF 001 and/or DELF 015 according to CCAM) Placement of single-chamber endovascular defibrillator (DELF 013 according to CCAM) Placement of dual-chamber endovascular defibrillator (DELF 015 according to CCAM) Placement of multi-site defibrillator (DELF 020 or DELF 014 according to CCAM) Primo Ablation Typical Atrial Flutter: Cavotricuspid Isthmus only (DEPF 012 according to CCAM) Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to CCAM) Accessory pathway ablation (DEPF 005 according to CCAM) Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per CCAM) Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to CCAM)
Who cannot join
- Patient whose procedure does not require X-rays
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology. The NR-Rythmo Study
Interventional radiology has become a widespread technique used in various fields of medicine to diagnose or treat numerous pathologies. However, the risk of X-rays must be taken into account. In 2019, the French Authority on Nuclear Safety published diagnostic reference levels for radio-guided interventional practices for 10 interventional radiology procedures and 2 interventional cardiology procedures, based on studies published by the French Society of Medical Physics in collaboration with the French Society of Radiology and the French Coronary Artery Disease and Interventional Cardiology Group. Reference levels for interventional procedures under CT guidance were also defined in 2020 following a national multicenter study coordinated by Nîmes University Hospital (NIMAO NRD-SI). However, no national multicentre studies have ever defined reference levels for radioguided interventional procedures in rhythmology. The aim of this study is to define standard national dosimetric levels for a number of radioguided interventional procedures in rhythmology.
Read the detailed description
Interventional radiology has become a widespread technique used in various fields of medicine to diagnose or treat numerous pathologies. However, the risk of X-rays must be taken into account.
To provide healthcare professionals with an optimization tool, the International Commission on Radiological Protection (ICRP) introduced the concept of diagnostic reference levels (DRLs) in 1997. For the first time, in 2019, the French Authority on Nuclear Safety published DRLs for radio-guided interventional practices for 10 interventional radiology procedures and 2 interventional cardiology procedures, based on studies published by the French Society of Medical Physics in collaboration with the French Society of Radiology and the French Coronary Artery Disease and Interventional Cardiology Group. Reference levels for interventional procedudures under CT guidance were also defined in 2020 following a national multicentre study coordinated by Nîmes University Hospital (NIMAO NRD-SI). However, no national multicentre studies have ever defined reference levels for radioguided interventional procedures in rhythmology. The aim of this study is to define standard national diagnostic reference levels for radioguided interventional procedures in rhythmology for the following acts:
- Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical acts)
- Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts)
- Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
- Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
- Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
- Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
- Typical Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
- Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
- Accessory pathway ablation (DEPF 005 according to the common French classification for medical acts)
- Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
- Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts) Secondaires objectives include the evaluation of interventional practices for each procedure performed regarding the use of a fixed or mobile C-arm, the make, model and year of installation of the equipment used, deviation at last external quality control between displayed and measured dose area product and, if available, between displayed and measured Kair, the lowest/highest scan rates used during the procedure, use of graphy,lowest/highest scan rate(s) used during procedures, use of collimation during procedures, use of a 3D mapping system, the type of technique used for an ablation procedure, if used, the use of a cage-type radiation protection system during the procedure, cone beam computed tomography performed during procedure, CT scan before the procedure, duration of the procedure and the experience of the operator performing the procedure.
- Conditions
- Radiology, Interventional, Heart Rhythm Disorders
- Being tested
- Radio-guided interventions to correct heart rhythm disorders
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-guided interventions to correct heart rhythm disordersRadiation
All patients in the cohort will be undergoing one of the following radio-guided procedures :
- Insertion of a single-chamber pacemaker with lead
- Insertion of a dual-chamber pacemaker with lead
- Implantation of a multi-site pacemaker
- Implantation of a single-chamber endovascular defibrillator
- Implantation of a dual-chamber endovascular defibrillator
- Placement of multi-site defibrillator
- Typical Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only
- Primo Ablation tachycardia by intra nodal re-entry
- Accessory pathway ablation
- Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined
- Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing radio-guided interventional radiology | All patients undergoing interventional radiology to correct heart rhythm disorders Receives: Radiation: Radio-guided interventions to correct heart rhythm disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
Quantitative
Measured: Day 1 of the intervention
Radiation dose: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
Quantitative
Measured: Day 1 of the intervention
Radiation dose: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
Quantitative
Measured: Day 1 of the intervention
Radiation dose: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
Quantitative
Measured: Day 1 of the intervention
Radiation dose: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common classification for medical acts)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
Quantitative
Measured: Day 1 of the intervention
Radiation dose: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma : Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
Quantitative
Measured: Day 1 of the intervention
Radiation dose : Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 day of the intervention
Total Air Kerma: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
Quantitative
Measured: Day 1 of the intervention
Radiation dose: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
Quantitative
Measured: Day 1 of the intervention
Radiation dose: pathway ablation (DEPF 005 according to the common French classification for medical acts)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma: pathway ablation (DEPF 005 according to the common French classification for medical acts)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: pathway ablation (DEPF 005 according to the common French classification for medical acts)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: pathway ablation (DEPF 005 according to the common French classification for medical acts)
Quantitative
Measured: Day 1 of the intervention
Radiation dose: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
Quantitative
Measured: Day 1 of the intervention
Radiation dose: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts)
Total Dose Area Product for the procedure measured in Gy.cm2
Measured: Day 1 of the intervention
Total Air Kerma: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Measured: Day 1 of the intervention
Total scanning time: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts)
The total scanning time for the procedure will be measured in seconds
Measured: Day 1 of the intervention
Total number of images: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts)
Quantitative
Measured: Day 1 of the intervention
Secondary outcomes (15)
Use of a fixed or mobile C-arm in each of the above 11 interventions
YES /NO
Measured: Day 1 of the intervention
Equipment
The make, model and year of commissioning the C-arm used will be recorded.
Measured: Day 1 of the intervention
Deviation between the Dose Area Product displayed and measured
The date of the last mandatory Quality Control and deviation between the Dose Area Product displayed and actually measured will be recorded.
Measured: Day 1 of the intervention
Deviation between the total air Kerma displayed and measured
The date of the last mandatory Quality Control and deviation between the total air Kerma displayed and actually measured will be recorded.
Measured: Day 1 of the intervention
Lowest/highest fluoroscopy frame rates
The lowest/highest frame rates used during fluoroscopy procedures will be measured in p/s
Measured: Day 1 of the intervention
Use of fluorography
YES/NO
Measured: Day 1 of the intervention
Lowest /highest fluorography rates
The lowest/highest frame rates used during fluorography procedures will be measured in p/s
Measured: Day 1 of the intervention
Use of collimation during each of the above 11 procedures ?
YES/NO
Measured: Day 1 of the intervention
Use of a 3D mapping system during each of the above 11 procedures ?
YES/NO
Measured: Day 1 of the intervention
Technique used for ablation
The type of technique used for ablation procedures will be recorded
Measured: Day 1 of the intervention
Use of a collective radiation protection system during each of the above 11 procedures ?
YES/NO
Measured: Day 1 of the intervention
Cone Beam Computed Tomography performed during any of the procedures above ?
YES/NO
Measured: Day 1 of the intervention
CT scan before a paroxysmal atrial fibrillation ablation procedure ?
YES/NO
Measured: Day 1 of the intervention
Duration of each of the above procedures
The duration of each of the above procedures will be recorded in minutes
Measured: Day 1 of the intervention
Rhythmologist's experience
The number of years of experience of the surgeon who performed the procedure will be recorded in years
Measured: Day 1 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 May 2024
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Radiology, InterventionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,219 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre François Winum, Dr., Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507085
- Sponsor's protocol ID
- NIMAO/2023-2/JG-01
- Acronym
- NR-Rythmo
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amara W, Socie P, Renault C, Taieb J. [Where are done electrophysiology procedures in France and what is the expected evolution ?]. Ann Cardiol Angeiol (Paris). 2022 Nov;71(5):294-298. doi: 10.1016/j.ancard.2022.08.010. French.
PubMed 36424019Etard C, Bigand E, Salvat C, Vidal V, Beregi JP, Hornbeck A, Greffier J. Patient dose in interventional radiology: a multicentre study of the most frequent procedures in France. Eur Radiol. 2017 Oct;27(10):4281-4290. doi: 10.1007/s00330-017-4780-5. Epub 2017 Mar 13.
PubMed 28289939Greffier J, Ferretti G, Rousseau J, Andreani O, Alonso E, Rauch A, Gillet R, Le Roy J, Cabrol-Faivre L, Douane F, David A, Henry S, Jacques T, Stefanovic X, Decoux E, Lafay F, Pilleul F, Couzon F, Boutet C, Woerly B, Baur P, Sans N, Faruch M, Moussier-Lherm A, Tselikas L, Jacquier A, Bigand E, Pessis E, Teriitehau C, Magnier F, Cassagnes L, Haberlay M, Boutteau D, De Kerviler E, Majorel-Gouthain C, Defez D, Vuillod A, Rouviere O, Hennequin L, Fohlen A, Alwan R, Malakhia A, Aubry S, Dohan A, Eresue-Bony M, Gautier R, Dal R, Dabli D, Hebert T, Kovacs R, Hadid-Beurrier L, Bousson V, Potel M, Barbotteau Y, Michel C, Habib-Geryes B, Andre M, Arnaud T, Bestion N, Ernst O, Monfraix S, Brillet PY, Guiu B, Boussel L, Demonchy M, Beregi JP, Frandon J. National dose reference levels in computed tomography-guided interventional procedures-a proposal. Eur Radiol. 2020 Oct;30(10):5690-5701. doi: 10.1007/s00330-020-06903-9. Epub 2020 May 2.
PubMed 32361774Bar O, Maccia C, Pages P, Blanchard D. A multicentre survey of patient exposure to ionising radiation during interventional cardiology procedures in France. EuroIntervention. 2008 Mar;3(5):593-9. doi: 10.4244/eijv3i5a107.
PubMed 19608487Radiological protection and safety in medicine. A report of the International Commission on Radiological Protection. Ann ICRP. 1996;26(2):1-47. No abstract available.
PubMed 8911634Diagnostic reference levels in medical imaging: review and additional advice. Ann ICRP. 2001;31(4):33-52.
PubMed 12685758Greffier J, Dhombres E, Dabli D, de Guillebon M, Charalampatou P, Feghali JA, Ganacheau E, du Roure VD, Goutain-Majorel C, Royer B, Milhem A, Arsac P, David S, Diot-Vaschy M, Serzian G, Chatterjee B, Frey P, Guenet A, Perrin B, Fernandez A, Couzon F, Costa AD, Leleu C, Taylor A, Behaghel V, Bestion N, Roy JL, Faivre LC, Michel M, Degand B, Collet S, Burguin E, Pichenot C, Fromentin S, Paul D, Girard-Bertrand B, Varlet E, Fitton I, Guerra R, Bottlaender E, Vaze AS, Monfraix S, Lepillier A, Paziaud O, Desflaches H, Brahic H, Serrand C, Roux J, Cayla G, Winum PF. Radiation dose reference levels for the most common image-guided interventional cardiac electrophysiology and pacing procedures: a French multicentre survey. Phys Med. 2026 Aug;148:105898. doi: 10.1016/j.ejmp.2026.105898. Epub 2026 Jul 19.
PubMed 42472521
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology. The NR-Rythmo Study
- ClinicalTrials.gov ID
- NCT06507085
- Acronym / sponsor ID
- NR-Rythmo / NIMAO/2023-2/JG-01
- Conditions
- Radiology, Interventional, Heart Rhythm Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,219 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interventional radiology has become a widespread technique used in various fields of medicine to diagnose or treat numerous pathologies. However, the risk of X-rays must be taken into account. In 2019, the French Authority on Nuclear Safety published diagnostic reference levels for radio-guided interventional practices for 10 interventional radiology procedures and 2 interventional cardiology procedures, based on studies published by the French Society of Medical Physics in collaboration with the French Society of Radiology and the French Coronary Artery Disease and Interventional Cardiology Group. Reference levels for interventional procedures under CT guidance were also defined in 2020 following a national multicenter study coordinated by Nîmes University Hospital (NIMAO NRD-SI). However, no national multicentre studies have ever defined reference levels for radioguided interventional procedures in rhythmology. The aim of this study is to define standard national dosimetric levels for a number of radioguided interventional procedures in rhythmology.
Detailed description
Interventional radiology has become a widespread technique used in various fields of medicine to diagnose or treat numerous pathologies. However, the risk of X-rays must be taken into account.
To provide healthcare professionals with an optimization tool, the International Commission on Radiological Protection (ICRP) introduced the concept of diagnostic reference levels (DRLs) in 1997. For the first time, in 2019, the French Authority on Nuclear Safety published DRLs for radio-guided interventional practices for 10 interventional radiology procedures and 2 interventional cardiology procedures, based on studies published by the French Society of Medical Physics in collaboration with the French Society of Radiology and the French Coronary Artery Disease and Interventional Cardiology Group. Reference levels for interventional procedudures under CT guidance were also defined in 2020 following a national multicentre study coordinated by Nîmes University Hospital (NIMAO NRD-SI). However, no national multicentre studies have ever defined reference levels for radioguided interventional procedures in rhythmology. The aim of this study is to define standard national diagnostic reference levels for radioguided interventional procedures in rhythmology for the following acts:
- Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical acts)
- Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts)
- Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
- Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
- Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
- Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
- Typical Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
- Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
- Accessory pathway ablation (DEPF 005 according to the common French classification for medical acts)
- Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
- Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts) Secondaires objectives include the evaluation of interventional practices for each procedure performed regarding the use of a fixed or mobile C-arm, the make, model and year of installation of the equipment used, deviation at last external quality control between displayed and measured dose area product and, if available, between displayed and measured Kair, the lowest/highest scan rates used during the procedure, use of graphy,lowest/highest scan rate(s) used during procedures, use of collimation during procedures, use of a 3D mapping system, the type of technique used for an ablation procedure, if used, the use of a cage-type radiation protection system during the procedure, cone beam computed tomography performed during procedure, CT scan before the procedure, duration of the procedure and the experience of the operator performing the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing radio-guided interventional radiology | – | Radiation: Radio-guided interventions to correct heart rhythm disordersAll patients undergoing interventional radiology to correct heart rhythm disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population: All patients benefitting from a rhythmology procedure to be performed among the procedures defined in the inclusion criteria.
Key inclusion criteria (4 listed)
- Adult male/female patient (≥ 18 years)
- Body Mass Index (BMI) between 18 and 35 kg/m².
- Patient to benefit from one of the following procedures:
- Placement of single-chamber pacemaker with lead (DELF 007 according to CCAM) Dual-chamber pacemaker insertion with lead (DELF 005 according to CCAM) Multi-site pacemaker placement (DELF 001 and/or DELF 015 according to CCAM) Placement of single-chamber endovascular defibrillator (DELF 013 according to CCAM) Placement of dual-chamber endovascular defibrillator (DELF 015 according to CCAM) Placement of multi-site defibrillator (DELF 020 or DELF 014 according to CCAM) Primo Ablation Typical Atrial Flutter: Cavotricuspid Isthmus only (DEPF 012 according to CCAM) Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to CCAM) Accessory pathway ablation (DEPF 005 according to CCAM) Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per CCAM) Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to CCAM)
Key exclusion criteria (2 listed)
- Patient whose procedure does not require X-rays
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radio-guided interventions to correct heart rhythm disordersAll patients in the cohort will be undergoing one of the following radio-guided procedures : * Insertion of a single-chamber pacemaker with lead * Insertion of a dual-chamber pacemaker with lead * Implantation of a multi-site pacemaker * Implantation of a single-chamber endovascular defibrillator * Implantation of a dual-chamber endovascular defibrillator * Placement of multi-site defibrillator * Typical Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only * Primo Ablation tachycardia by intra nodal re-entry * Accessory pathway ablation * Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined * Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate | Radiation | Patients undergoing radio-guided interventional radiology |
Primary outcome
Radiation dose: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
Time frame: Day 1 of the intervention
Quantitative
Radiation dose: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
Time frame: Day 1 of the intervention
Quantitative
Radiation dose: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Quantitative
Radiation dose: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Quantitative
Radiation dose: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common classification for medical acts)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Quantitative
Radiation dose: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma : Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Quantitative
Radiation dose : Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
Time frame: Day 1 day of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Quantitative
Radiation dose: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Quantitative
Radiation dose: pathway ablation (DEPF 005 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: pathway ablation (DEPF 005 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: pathway ablation (DEPF 005 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: pathway ablation (DEPF 005 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Quantitative
Radiation dose: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
Time frame: Day 1 of the intervention
Quantitative
Radiation dose: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
The total scanning time for the procedure will be measured in seconds
Total number of images: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts)
Time frame: Day 1 of the intervention
Quantitative
15 secondary outcomes
Use of a fixed or mobile C-arm in each of the above 11 interventions
Time frame: Day 1 of the intervention
Equipment
Time frame: Day 1 of the intervention
Deviation between the Dose Area Product displayed and measured
Time frame: Day 1 of the intervention
Deviation between the total air Kerma displayed and measured
Time frame: Day 1 of the intervention
Lowest/highest fluoroscopy frame rates
Time frame: Day 1 of the intervention
Use of fluorography
Time frame: Day 1 of the intervention
Lowest /highest fluorography rates
Time frame: Day 1 of the intervention
Use of collimation during each of the above 11 procedures ?
Time frame: Day 1 of the intervention
Use of a 3D mapping system during each of the above 11 procedures ?
Time frame: Day 1 of the intervention
Technique used for ablation
Time frame: Day 1 of the intervention
Use of a collective radiation protection system during each of the above 11 procedures ?
Time frame: Day 1 of the intervention
Cone Beam Computed Tomography performed during any of the procedures above ?
Time frame: Day 1 of the intervention
CT scan before a paroxysmal atrial fibrillation ablation procedure ?
Time frame: Day 1 of the intervention
Duration of each of the above procedures
Time frame: Day 1 of the intervention
Rhythmologist's experience
Time frame: Day 1 of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 36424019Amara W, Socie P, Renault C, Taieb J. [Where are done electrophysiology procedures in France and what is the expected evolution ?]. Ann Cardiol Angeiol (Paris). 2022 Nov;71(5):294-298. doi: 10.1016/j.ancard.2022.08.010. French.
- Background: PubMed 28289939Etard C, Bigand E, Salvat C, Vidal V, Beregi JP, Hornbeck A, Greffier J. Patient dose in interventional radiology: a multicentre study of the most frequent procedures in France. Eur Radiol. 2017 Oct;27(10):4281-4290. doi: 10.1007/s00330-017-4780-5. Epub 2017 Mar 13.
- Background: PubMed 32361774Greffier J, Ferretti G, Rousseau J, Andreani O, Alonso E, Rauch A, Gillet R, Le Roy J, Cabrol-Faivre L, Douane F, David A, Henry S, Jacques T, Stefanovic X, Decoux E, Lafay F, Pilleul F, Couzon F, Boutet C, Woerly B, Baur P, Sans N, Faruch M, Moussier-Lherm A, Tselikas L, Jacquier A, Bigand E, Pessis E, Teriitehau C, Magnier F, Cassagnes L, Haberlay M, Boutteau D, De Kerviler E, Majorel-Gouthain C, Defez D, Vuillod A, Rouviere O, Hennequin L, Fohlen A, Alwan R, Malakhia A, Aubry S, Dohan A, Eresue-Bony M, Gautier R, Dal R, Dabli D, Hebert T, Kovacs R, Hadid-Beurrier L, Bousson V, Potel M, Barbotteau Y, Michel C, Habib-Geryes B, Andre M, Arnaud T, Bestion N, Ernst O, Monfraix S, Brillet PY, Guiu B, Boussel L, Demonchy M, Beregi JP, Frandon J. National dose reference levels in computed tomography-guided interventional procedures-a proposal. Eur Radiol. 2020 Oct;30(10):5690-5701. doi: 10.1007/s00330-020-06903-9. Epub 2020 May 2.
- Background: PubMed 19608487Bar O, Maccia C, Pages P, Blanchard D. A multicentre survey of patient exposure to ionising radiation during interventional cardiology procedures in France. EuroIntervention. 2008 Mar;3(5):593-9. doi: 10.4244/eijv3i5a107.
- Background: PubMed 8911634Radiological protection and safety in medicine. A report of the International Commission on Radiological Protection. Ann ICRP. 1996;26(2):1-47. No abstract available.
- Background: PubMed 12685758Diagnostic reference levels in medical imaging: review and additional advice. Ann ICRP. 2001;31(4):33-52.
- Results publication: PubMed 42472521Greffier J, Dhombres E, Dabli D, de Guillebon M, Charalampatou P, Feghali JA, Ganacheau E, du Roure VD, Goutain-Majorel C, Royer B, Milhem A, Arsac P, David S, Diot-Vaschy M, Serzian G, Chatterjee B, Frey P, Guenet A, Perrin B, Fernandez A, Couzon F, Costa AD, Leleu C, Taylor A, Behaghel V, Bestion N, Roy JL, Faivre LC, Michel M, Degand B, Collet S, Burguin E, Pichenot C, Fromentin S, Paul D, Girard-Bertrand B, Varlet E, Fitton I, Guerra R, Bottlaender E, Vaze AS, Monfraix S, Lepillier A, Paziaud O, Desflaches H, Brahic H, Serrand C, Roux J, Cayla G, Winum PF. Radiation dose reference levels for the most common image-guided interventional cardiac electrophysiology and pacing procedures: a French multicentre survey. Phys Med. 2026 Aug;148:105898. doi: 10.1016/j.ejmp.2026.105898. Epub 2026 Jul 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre François Winum, Dr. principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiology, Interventional and Heart Rhythm Disorders, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures) (time frame: Day 1 of the intervention). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06507085, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.