Evaluating Varipulse Catheter Ablation Using Different Anesthesia Types in Adults With Paroxysmal Atrial Fibrillation

What This Trial Is About

Researchers are evaluating the long-term effectiveness of a standard ablation procedure using the Varipulse Catheter in people with symptomatic paroxysmal atrial fibrillation PAF, which causes irregular heartbeats that come and go and can produce symptoms like a racing heart or shortness of breath. This observational study compares the procedure outcomes when performed under different types of anesthesia to better understand their impact. Participants are divided into two groups based on the anesthesia used during their ablation one group receives general anesthesia, and the other receives non-general anesthesia, which includes deep sedation or conscious sedation. Both groups undergo pulsed field ablation PFA using the Varipulse PFA catheter system, which consists of the Varipulse catheter and the Trupulse generator. The study tracks these treatments during the procedure and afterwards to assess their effects. During the study, participants will be monitored closely through various assessments, including heart rhythm checks for atrial tachyarrhythmias from day 91 to day 365 after the procedure. Researchers will also evaluate acute procedural success, quality of life related to atrial fibrillation, procedure and mapping times, sedation levels, pain scores, and any repeat ablation needs up to 12 months post-procedure. The study aims to provide a comprehensive view of treatment outcomes and participant experience over the course of about one year after the ablation.

A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation