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 System, or LAAO Device. The registry lists allocation as randomized. This study wants to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease).
They plan to enroll about 1,070 people at 13 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Assessment of the Safety and Effectiveness of the VARIPULSE™ Catheter System in the Treatment of Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein (With or Without Posterior Wall Isolation) and Superior Vena Cava Isolation: A Randomized Controlled Trial
Interventions: VARIPULSE Catheter System, LAAO Device
Primary outcome (registry wording): Number of Participants with Early Onset Primary Adverse Events (PAEs)