The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation (PF-MRI)

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Atrial Fibrillation Paroxysmal

Treatments

Procedure: Pulmonary vein isolation by cryoablation

Procedure: Pulmonary vein isolation by pulse field ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT06557876

APHP230296

Details and patient eligibility

About

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

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.