What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are VARIPULSE Catheter, or FARAWAVE Catheter. The registry lists allocation as randomized. This study wants to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
They plan to enroll about 566 people at 20 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial
Interventions: VARIPULSE Catheter, FARAWAVE Catheter
Primary outcome (registry wording): Occurrence of Early Onset Primary Adverse Events (PAEs)