Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorR&D Cardiologie

About this trial

Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations.

Eligibility criteria

Qualifiers

Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND

Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR

Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past

Disqualifiers

Cerebrovascular accident (CVA) in the last 6 months

More than moderate valvular disease that would require intervention

Cardiac catheter/surgical intervention in the last 3 months or scheduled

Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past

Trial design

Treatments tested in this trial

  • Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation
  • Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation

Treatment groups

378 Participants
are divided into 2 treatment groups

Sponsors and collaborators