Auricular FlutterDOSIMETRY-AFLNCT03946280
Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry
A study testing conventional X-ray based Fluoroscopy and low X-ray 3D navigation technique in people with Auricular Flutter and Radiation Exposure, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Common Flutter ablation technique use low X-ray based three-dimension (3D) navigation for catheter tracking, have become a popular implementation to treat patient's underlying arrhythmia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auricular Flutter, Radiation Exposure
- What is being tested?
- conventional X-ray based Fluoroscopy and low X-ray 3D navigation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2018to 1 Nov 2020
- Phase
- Interventional
- 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
Who may be able to join
- Sick adult patients with Atrial Flutter arrythmia
- patients able to consent.
- patients scheduled to receive cavotricuspid isthmus ablation treatment
Who cannot join
- patients who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Yovan Sanchez Ruiz, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires St Luc
Brussels, 1200
Yovan SANCHEZ RUIZ, ysanchezruiz@student.uclouvain.be
Christophe SCAVEE, 3227642808, christophe.scavee@uclouvain.be
About this study
Common Flutter ablation technique use low X-ray based three-dimension (3D) navigation for catheter tracking, have become a popular implementation to treat patient's underlying arrhythmia. Compared with fluoroscopy, the gold standard X-ray based method, this recent technique provides the required anatomical information and reduce risk associated with ionizing radiation exposure. Besides Practical Guidelines "as low as reasonably achievable (ALARA) to minimize and normalize radiation exposure had been published so far. The risk of developing acute radiation associated injuries still remains high. In the present study we will compare two groups of patients undergoing into cavotricuspid isthmus (CTI) ablation using either the 3D navigation ("Ensite NavX system") (n = 25) or conventional fluoroscopy (n = 25). Further developing the 3D navigation technique will help to increase safety during the treatment, for both patients and the personnel and increase the success rate during the electrophysiological (EP) interventional procedures.
- Conditions
- Auricular Flutter, Radiation Exposure
- Being tested
- conventional X-ray based Fluoroscopy, low X-ray 3D navigation technique
- Keywords
- ALARA, radiation exposure, Flutter ablation
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional X-ray based FluoroscopyProcedure or surgery
catheter tracking via conventional X-ray based Fluoroscopy
low X-ray 3D navigation techniqueProcedure or surgery
catheter tracking via low X-ray 3D navigation technique
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopy Group | Other | Patient undergoing common flutter (AFL) ablation procedure using conventional X-ray based fluoroscopy for for catheter tracking Receives: Procedure: conventional X-ray based Fluoroscopy |
| 3D Group | Experimental | Patient undergoing common flutter (AFL) ablation procedure using the low X-ray 3D navigation technique for for catheter tracking Receives: Procedure: low X-ray 3D navigation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants
two groups and 25 patiens within each group
Measured: through study completion, an average of 2 year
age
age in years of every patient in the study
Measured: at the moment the patient was recruited for the study
Electrophysiology procedure time (EP time)
time the intervention last in minutes
Measured: at the moment of the intervention
Radiofrecuency ablation time
time radiofrecuency are applied within the EP time in minutes/ seconds
Measured: at the moment of the intervention
Total Fluoroscopy time
time the patiens receive x ray radiation along the intervention in minutes/ seconds
Measured: at the moment of the intervention
Time without fluoroscopy
time the patiens do not receive any x ray radiation along the intervention in minutes/ seconds
Measured: at the moment of the intervention
Dose area product
Global Radiation dose emited by the x-ray tube in mgcm2
Measured: at the moment of the intervention
Radiation dose TLD in patient (5 TLD)
five thermoluminescent dosimeters are placed on the body of the patient in mgcm2
Measured: at the moment of the intervention
Radiation dose TLD in operator (3 TLD)
three thermoluminescent dosimeters are placed on the body of the patient in mgcm2
Measured: at the moment of the intervention
readmission
times the patient is readmitted in the hospital
Measured: within 12 months following the EP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Nov 2018
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auricular FlutterStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study, patients are allocated to 1 of the 2 groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Scavée, PhD, Principal investigator, Cliniques Universitaires St Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946280
- Sponsor's protocol ID
- DOSIMETRY - FLUTTER
- Acronym
- DOSIMETRY-AFL
- Status last verified
- Jul 2019
- First submitted
- 8 May 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry
- ClinicalTrials.gov ID
- NCT03946280
- Acronym / sponsor ID
- DOSIMETRY-AFL / DOSIMETRY - FLUTTER
- Conditions
- Auricular Flutter, Radiation Exposure
- Keywords
- ALARA, radiation exposure, Flutter ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 10 May 2019 (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.
Common Flutter ablation technique use low X-ray based three-dimension (3D) navigation for catheter tracking, have become a popular implementation to treat patient's underlying arrhythmia. Compared with fluoroscopy, the gold standard X-ray based method, this recent technique provides the required anatomical information and reduce risk associated with ionizing radiation exposure. Besides Practical Guidelines "as low as reasonably achievable (ALARA) to minimize and normalize radiation exposure had been published so far. The risk of developing acute radiation associated injuries still remains high. In the present study we will compare two groups of patients undergoing into cavotricuspid isthmus (CTI) ablation using either the 3D navigation ("Ensite NavX system") (n = 25) or conventional fluoroscopy (n = 25). Further developing the 3D navigation technique will help to increase safety during the treatment, for both patients and the personnel and increase the success rate during the electrophysiological (EP) interventional procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized study, patients are allocated to 1 of the 2 groups
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopy Group | Other | Procedure: conventional X-ray based FluoroscopyPatient undergoing common flutter (AFL) ablation procedure using conventional X-ray based fluoroscopy for for catheter tracking |
| 3D Group | Experimental | Procedure: low X-ray 3D navigation techniquePatient undergoing common flutter (AFL) ablation procedure using the low X-ray 3D navigation technique for for catheter tracking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sick adult patients with Atrial Flutter arrythmia
- patients able to consent.
- patients scheduled to receive cavotricuspid isthmus ablation treatment
Key exclusion criteria (1 listed)
- patients who do not meet inclusion criteria
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 |
|---|---|---|
| conventional X-ray based Fluoroscopycatheter tracking via conventional X-ray based Fluoroscopy | Procedure or surgery | Fluoroscopy Group |
| low X-ray 3D navigation techniquecatheter tracking via low X-ray 3D navigation technique | Procedure or surgery | 3D Group |
Primary outcome
Number of Participants
Time frame: through study completion, an average of 2 year
two groups and 25 patiens within each group
age
Time frame: at the moment the patient was recruited for the study
age in years of every patient in the study
Electrophysiology procedure time (EP time)
Time frame: at the moment of the intervention
time the intervention last in minutes
Radiofrecuency ablation time
Time frame: at the moment of the intervention
time radiofrecuency are applied within the EP time in minutes/ seconds
Total Fluoroscopy time
Time frame: at the moment of the intervention
time the patiens receive x ray radiation along the intervention in minutes/ seconds
Time without fluoroscopy
Time frame: at the moment of the intervention
time the patiens do not receive any x ray radiation along the intervention in minutes/ seconds
Dose area product
Time frame: at the moment of the intervention
Global Radiation dose emited by the x-ray tube in mgcm2
Radiation dose TLD in patient (5 TLD)
Time frame: at the moment of the intervention
five thermoluminescent dosimeters are placed on the body of the patient in mgcm2
Radiation dose TLD in operator (3 TLD)
Time frame: at the moment of the intervention
three thermoluminescent dosimeters are placed on the body of the patient in mgcm2
readmission
Time frame: within 12 months following the EP
times the patient is readmitted in the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Auricular Flutter
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
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.
Yovan Sanchez Ruiz, PhD contact
Christophe Scavée, PhD principal investigator
Cliniques Universitaires St Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional X-ray based Fluoroscopy and low X-ray 3D navigation technique in people with Auricular Flutter and Radiation Exposure, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jul 2019. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Scavée, PhD, MD (+3227642808, christophe.scavee@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants (time frame: through study completion, an average of 2 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2019.