Cardiac MRIVAIMTH-IRMNCT03031587
Validation of Thermometric Cardiac Imaging by MRI
A study testing Additional MRI acquisition sequences and MRI in people with Cardiac MRI, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias resistant to medication. However, the absence of assessment of injury creation during radiofrequency application is an important issue. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cardiac MRI
- What is being tested?
- Additional MRI acquisition sequences and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2017to 13 Jun 2019
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient requiring, as part of his/her traditional management of an MRI imaging examination
- Adults (age greater than or equal to 18 years) of both sexes
- Minors (aged 15 to 18) of both sexes subject to the parental agreement or its legal representative
- Patient's oral agreement after reading the information note
- Patient affiliate or beneficiary of a social security scheme.
Who cannot join
- Patients under 15 years of age
- Patient unable to give oral consent
- Patients in periods of relative exclusion in relation to another protocol
- Patient deprived of liberty by judicial or administrative decision
- Major protected by the law
- Patient who does not meet the eligibility criteria for an MRI examination with or without injection.
Trial locations and contacts
1 site in 1 country.
About this study
Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias resistant to medication. However, the absence of assessment of injury creation during radiofrequency application is an important issue. One of the objectives of the Institut Hospitalo-Universitaire (IHU) Liryc (l'Institut de Rythmologie et Modélisation Cardiaque) is to improve ablation procedures by radiofrequency of cardiac arrhythmias. This is based on thermometric imaging by Magnetic Resonance Imaging (MRI) which allows a real time visualization of tissue temperature in all the myocardium with sufficient spatial and temporal resolution to characterize the induced thermal lesion. Today, investigators have developed and validated a new method for cardiac thermometry, associating rapid MRI acquisition technique (4 to 5 slices per heart beat) with online image reconstruction and correction algorithms against residual motion, magnetic susceptibility, drift of the magnetic field, etc... Recent preclinical studies showed a precision of 1°Celsius in the myocardium, largely sufficient to characterize a thermal treatment induced by radiofrequency where typical temperature rises of 40°C are observed during ablation. Temporal evolution of the temperature in each pixel provides access to calculation of the accumulated thermal dose that is a relevant indicator of the induced necrosis.
This imaging method must now be evaluated in humans in order to test its robustness under real conditions (presence of arrhythmias, corpulent patients, etc…) and to optimize acquisition parameters and image processing. The aim of this research is thus to obtain specific MRI sequence of images of patients, on which will be evaluated the different algorithms of reconstruction and processing for temperature imaging. This study is a mandatory step in the perspective of future clinical treatments of cardiac arrhythmia under MRI.
Read the detailed description
Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias resistant to medication. However, the absence of assessment of injury creation during radiofrequency application is an important issue in that it can result either in recurrences of arrhythmia requiring redo procedures when an inadequate lesion is created, or on the opposite in serious complications when the lesion created is too large and extents to extra-cardiac territory that should be preserved. The imaging team of the IHU-Liryc develops new methods in cardiac MRI in view of diagnostics (improve spatial and temporal resolution, dynamic 3D imaging or contrast improvement) and therapeutics. Hence, one of the objectives of the IHU-Liryc is to improve ablation procedures by radiofrequency of cardiac arrhythmias in order to make them more effective (Real-time visualization of the thermal lesion, allowing application of the sufficient energy needed for a transmural lesion), and safer avoiding excessive lesion responsible for perforation and extension to extra-cardiac structures. This is based on thermometric imaging by MRI which allows a real time visualization of tissue temperature in all the myocardium with sufficient spatial and temporal resolution to characterize the induced thermal lesion. MRI thermometry was developed during the last decade and successfully applied clinically over a wide range of organs (the uterus, the brain, the liver, the kidneys) for direct monitoring of thermal treatment of various pathologies (fibroids Uterus, bone metastasis, liver cancer). This innovative technic was not applicable to cardiac arrhythmias due to the respiratory and cardiac movements whose rhythms can be irregular, as well as thermal noise generated by blood flow on images. Today, our team has developed and preclinically validated a new rapid MRI method dedicated to cardiac thermometry. All patients who give their oral agreement to participate to the study will have added to their examination some acquisition sequences. The maximum additional time due to the specific acquisitions of the study will be 5 minutes, over an average clinical examination time of 45 minutes. No follow-up or visit of end of treatment will be performed, the end of patient participation in this research corresponding to the end of the MRI examination.
- Conditions
- Cardiac MRI
- Being tested
- Additional MRI acquisition sequences, MRI
- Keywords
- Thermometric MRI, Myocardium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional MRI acquisition sequencesOther
It deals with specific sequences of rapid imaging acquisition in gradient echo (4 to 5 slices/cardiac cycle) with synchronization on the surface ECG systematically included in a cardiac MRI examination, together with update of the slice position depending on the respiratory state (established technique of navigator echo). The acquisition is repeated over 300 cardiac cycles to monitor myocardial temperature changes
MRIDevice
cardiac MRI
| Study group | Role | What they receive |
|---|---|---|
| MRI examination | Experimental | Each patient coming to the hospital for cardiac MRI examination can participate to the study if he/she meets the eligibility criteria Receives: Other: Additional MRI acquisition sequences; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of the temperature variance of various measurements realized in a region of interest of the myocardium
1 measurement of temperature (°C) by cardiac beating
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start24 May 2017
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac MRIStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre JAÏS, MD PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031587
- Sponsor's protocol ID
- CHUBX 2016/15
- Other IDs
- 2016-A01578-43
- Acronym
- VAIMTH-IRM
- Status last verified
- Feb 2020
- First submitted
- 23 Jan 2017
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozenne V, Bour P, de Senneville BD, Toupin S, Vaussy A, Lepetit-Coiffe M, Jais P, Cochet H, Quesson B. Assessment of left ventricle magnetic resonance temperature stability in patients in the presence of arrhythmias. NMR Biomed. 2019 Nov;32(11):e4160. doi: 10.1002/nbm.4160. Epub 2019 Aug 9.
PubMed 31397942
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Thermometric Cardiac Imaging by MRI
- ClinicalTrials.gov ID
- NCT03031587
- Acronym / sponsor ID
- VAIMTH-IRM / CHUBX 2016/15
- Conditions
- Cardiac MRI
- Keywords
- Thermometric MRI, Myocardium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias resistant to medication. However, the absence of assessment of injury creation during radiofrequency application is an important issue. One of the objectives of the Institut Hospitalo-Universitaire (IHU) Liryc (l'Institut de Rythmologie et Modélisation Cardiaque) is to improve ablation procedures by radiofrequency of cardiac arrhythmias. This is based on thermometric imaging by Magnetic Resonance Imaging (MRI) which allows a real time visualization of tissue temperature in all the myocardium with sufficient spatial and temporal resolution to characterize the induced thermal lesion. Today, investigators have developed and validated a new method for cardiac thermometry, associating rapid MRI acquisition technique (4 to 5 slices per heart beat) with online image reconstruction and correction algorithms against residual motion, magnetic susceptibility, drift of the magnetic field, etc... Recent preclinical studies showed a precision of 1°Celsius in the myocardium, largely sufficient to characterize a thermal treatment induced by radiofrequency where typical temperature rises of 40°C are observed during ablation. Temporal evolution of the temperature in each pixel provides access to calculation of the accumulated thermal dose that is a relevant indicator of the induced necrosis.
This imaging method must now be evaluated in humans in order to test its robustness under real conditions (presence of arrhythmias, corpulent patients, etc…) and to optimize acquisition parameters and image processing. The aim of this research is thus to obtain specific MRI sequence of images of patients, on which will be evaluated the different algorithms of reconstruction and processing for temperature imaging. This study is a mandatory step in the perspective of future clinical treatments of cardiac arrhythmia under MRI.
Detailed description
Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias resistant to medication. However, the absence of assessment of injury creation during radiofrequency application is an important issue in that it can result either in recurrences of arrhythmia requiring redo procedures when an inadequate lesion is created, or on the opposite in serious complications when the lesion created is too large and extents to extra-cardiac territory that should be preserved. The imaging team of the IHU-Liryc develops new methods in cardiac MRI in view of diagnostics (improve spatial and temporal resolution, dynamic 3D imaging or contrast improvement) and therapeutics. Hence, one of the objectives of the IHU-Liryc is to improve ablation procedures by radiofrequency of cardiac arrhythmias in order to make them more effective (Real-time visualization of the thermal lesion, allowing application of the sufficient energy needed for a transmural lesion), and safer avoiding excessive lesion responsible for perforation and extension to extra-cardiac structures. This is based on thermometric imaging by MRI which allows a real time visualization of tissue temperature in all the myocardium with sufficient spatial and temporal resolution to characterize the induced thermal lesion. MRI thermometry was developed during the last decade and successfully applied clinically over a wide range of organs (the uterus, the brain, the liver, the kidneys) for direct monitoring of thermal treatment of various pathologies (fibroids Uterus, bone metastasis, liver cancer). This innovative technic was not applicable to cardiac arrhythmias due to the respiratory and cardiac movements whose rhythms can be irregular, as well as thermal noise generated by blood flow on images. Today, our team has developed and preclinically validated a new rapid MRI method dedicated to cardiac thermometry. All patients who give their oral agreement to participate to the study will have added to their examination some acquisition sequences. The maximum additional time due to the specific acquisitions of the study will be 5 minutes, over an average clinical examination time of 45 minutes. No follow-up or visit of end of treatment will be performed, the end of patient participation in this research corresponding to the end of the MRI examination.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI examination | Experimental | Other: Additional MRI acquisition sequences, Device: MRIEach patient coming to the hospital for cardiac MRI examination can participate to the study if he/she meets the eligibility criteria |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient requiring, as part of his/her traditional management of an MRI imaging examination
- Adults (age greater than or equal to 18 years) of both sexes
- Minors (aged 15 to 18) of both sexes subject to the parental agreement or its legal representative
- Patient's oral agreement after reading the information note
- Patient affiliate or beneficiary of a social security scheme.
Key exclusion criteria (6 listed)
- Patients under 15 years of age
- Patient unable to give oral consent
- Patients in periods of relative exclusion in relation to another protocol
- Patient deprived of liberty by judicial or administrative decision
- Major protected by the law
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 |
|---|---|---|
| Additional MRI acquisition sequencesIt deals with specific sequences of rapid imaging acquisition in gradient echo (4 to 5 slices/cardiac cycle) with synchronization on the surface ECG systematically included in a cardiac MRI examination, together with update of the slice position depending on the respiratory state (established technique of navigator echo). The acquisition is repeated over 300 cardiac cycles to monitor myocardial temperature changes | Other | MRI examination |
| MRIcardiac MRI | Device | MRI examination |
Primary outcome
Calculation of the temperature variance of various measurements realized in a region of interest of the myocardium
Time frame: Day 0
1 measurement of temperature (°C) by cardiac beating
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 May 2026.
- Results publication: PubMed 31397942Ozenne V, Bour P, de Senneville BD, Toupin S, Vaussy A, Lepetit-Coiffe M, Jais P, Cochet H, Quesson B. Assessment of left ventricle magnetic resonance temperature stability in patients in the presence of arrhythmias. NMR Biomed. 2019 Nov;32(11):e4160. doi: 10.1002/nbm.4160. Epub 2019 Aug 9.
- Individual participant dataSharing planned: No
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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 JAÏS, MD PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional MRI acquisition sequences and MRI in people with Cardiac MRI, run by University Hospital, Bordeaux 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 5 inclusion and 6 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 May 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?
Calculation of the temperature variance of various measurements realized in a region of interest of the myocardium (time frame: Day 0). 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 NCT03031587, which also lists 1 linked publication.
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 May 2026.