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