NCT06557876Recruiting
The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation
The Effect of Pulse Field Ablation on Atrial Mechanics Assessed by MRI and on Patient-related Outcomes in Catheter Ablation of Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. The main question it aims to answer is: • Is catheter ablation energy (pulse field ablation) revealing a better preservation of the atrial function architecture than with conventional catheter ablation technologies ? Participants will performed 2 IRMs with injection and completed Quality of Life Questionnaires. They participate in the study for 4 months. Researchers will compare 2 arms: * Pulse-Field Ablation * Cryoablation
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 14 Aug 2024
- Start date
- 9 Oct 2024
- Primary completion date
- 9 Sept 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Atrial fibrillation
- NCT number
- NCT06557876
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 9 Oct 2024 to the primary completion date, 9 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ablation in the left atrium
- Previous heart surgery
- Participation in another interventional study or being in the exclusion period at the end of a previous study.
Other illness
- 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
Lab values
- 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)
Other
- Non-paroxysmal atrial fibrillation
- Contraindication to oral anticoagulation
- Intracardiac thrombus
- Patient on AME (state medical aid)
- Pregnant or breast-feeding female
- Patient protected by law (guardianship, tutelage measure, deprived of liberty)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr Mikael Laredo Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.