Long-Term Evaluation of VARIPULSE Catheter System for Treating Symptomatic Paroxysmal Atrial Fibrillation

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of the FDA-approved VARIPULSE catheter system for pulmonary vein isolation PVI in adults with symptomatic paroxysmal atrial fibrillation PAF. This device-based study focuses on participants who have not responded well or cannot tolerate at least one Class I or III antiarrhythmic drug and are candidates for catheter ablation. The goal is to monitor the outcomes of using this specific catheter system in managing PAF. Participants will undergo electrophysiology mapping and pulsed field ablation PFA using the VARIPULSE catheter combined with the TRUPULSE generator to perform pulmonary vein ablation. The study is a single-group design where all participants receive this intervention to treat their symptomatic PAF. The ablation procedure is followed by a long-term observation period to assess safety and effectiveness. During the study, participants will be closely monitored for early adverse events within 7 days after the ablation procedure and for freedom from documented atrial tachyarrhythmia episodes from day 61 up to 1095 days post-procedure. Assessments include follow-up testing and compliance with study requirements over this extended period to evaluate both short-term and long-term outcomes. The total study duration extends through 2030, with ongoing safety and effectiveness evaluations.

A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System