New heart procedure may better preserve heart function in AFib patients
NCT ID NCT06557876
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of catheter ablation for people with paroxysmal atrial fibrillation (a type of irregular heartbeat). The goal is to see if a newer method called pulse field ablation preserves heart muscle function better than the standard cryoablation. Eighty adults will undergo MRI scans and complete quality-of-life questionnaires over 4 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient age ≥ 18 * Established diagnosis of paroxysmal fibrillation, with a I/IIa/IIb indication for catheter ablation (ESC 2020 guidelines) * Episode of AF documented by ECG within the last 12 months * Patient able to give written informed consent * If female of childbearing potential, have a negative serum pregnancy test and using effective contraception * Be affiliated with a French social security system or entitled Exclusion Criteria: * Non-paroxysmal atrial fibrillation * Contraindication to oral anticoagulation * Intracardiac thrombus * Previous ablation in the left atrium * Previous heart surgery * Significant valvular heart disease defined as any moderate (grade 3) or severe (grade 4) mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or tricuspid stenosis * Contraindication to perform MRI or using the DOTAREM™ contrast product (pacemaker, defibrillator, foreign body or prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, percutaneous devices for endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic device, severe kidney disease with GFR \< 30 mL/min, documented hypersensitivity to gadoteric acid or to excipients, severe claustrophobia) * Patient on AME (state medical aid) * Pregnant or breast-feeding female * Patient protected by law (guardianship, tutelage measure, deprived of liberty) * Participation in another interventional study or being in the exclusion period at the end of a previous study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dr Mikael Laredo
RECRUITINGParis, France, 75013, France
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Other studies related to the condition(s) this trial covers.
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