Clinical Trial

A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation

Study acronym: PERSIGMA RCT
Recruiting
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Summary
The purpose of this study is 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).
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-08-06
notable Enrollment increased: 466 -> 566 participants 2026-08-01
notable Trial sites expanded: 11 -> 29 locations 2026-08-01
notable Trial sites expanded: 1 -> 11 locations 2026-06-06
critical Recruitment opened 2026-04-23
Trial Details
NCT Number NCT07523750
Lead Sponsor Biosense Webster, Inc.
Conditions Atrial Fibrillation
Enrollment 566 participants
Start Date 2026-04-02
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-05