Safety and Long-Term Effectiveness of the VARIPULSE Catheter System for Treating Persistent Atrial Fibrillation Using Pulmonary Vein, Superior Vena Cava, and Posterior Wall Isolation

What this Trial Is About

This trial is studying how safe and effective the VARIPULSE catheter system is for treating persistent atrial fibrillation PsAF, a heart rhythm disorder. It focuses on participants undergoing catheter ablation procedures that isolate veins in the heart, specifically pulmonary vein isolation PVI and superior vena cava isolation SVCI, with or without posterior wall isolation PWI. The study also looks at safety for participants receiving a left atrial appendage occlusion LAAO procedure during the catheter ablation to reduce stroke risk. Participants will be treated with the VARIPULSE catheter system, which delivers pulsed field ablation, using the VARIPULSE bi-directional catheter and TRUPULSE generator. The study has two groups one undergoing PVI and SVCI, and another undergoing PVI, SVCI, plus PWI. Some participants may also receive the LAAO procedure using commercially available devices as per device instructions. All participants will be followed for up to 36 months after their procedure. During the study, participants will undergo catheter ablation treatment and may receive the LAAO procedure if applicable. Researchers will monitor safety by tracking early adverse events up to 7 days post-procedure and will assess how well the treatment prevents atrial tachyarrhythmia episodes from day 61 to 180 and up to one year. Quality of life will be measured at baseline and 12 months after treatment. Participants need to comply with pre-, post-, and follow-up testing throughout the study and will be observed for up to three years in total.

A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation