The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation
Recruiting · NCT06557876 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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
Who can take part
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.
Where it is running
1 location listed.
- Dr Mikael Laredo - Paris, France, France