Validation of Thermometric Cardiac Imaging by MRI (VAIMTH-IRM)

May 11, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33604
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI examination
Each patient coming to the hospital for cardiac MRI examination can participate to the study if he/she meets the eligibility criteria
Other: Additional MRI acquisition sequences
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
Device: MRI
cardiac MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Pierre JAÏS, MD PhD, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2017

Primary Completion (Actual)

June 13, 2019

Study Completion (Actual)

June 13, 2019

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimated)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHUBX 2016/15
  • 2016-A01578-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac MRI

Clinical Trials on Additional MRI acquisition sequences

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe