Status:
RECRUITING
The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Atrial Fibrillation Paroxysmal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 fibri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06557876
Start Date
October 9 2024
End Date
October 1 2026
Last Update
September 19 2025
Active Locations (1)
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1
Dr Mikael Laredo
Paris, France, France, 75013