Clinical Trial

A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF

Study acronym: VP-CONFIRM
Recruiting
View on ClinicalTrials.gov →
Summary
The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).
Protocol Amendment History 8 changes
critical Primary endpoint(s) modified 2026-07-14
critical Trial status changed: Withheld → Recruiting 2026-04-07
critical Phase changed: not specified -> not applicable 2026-04-07
critical Primary endpoint(s) modified 2026-04-07
notable Enrollment changed: None -> 50 2026-04-07
notable Sponsor changed: [Redacted] -> Biosense Webster, Inc. 2026-04-07
minor Trial arms changed: 0 -> 1 2026-04-07
notable Trial sites expanded: 0 -> 10 locations 2026-04-07
Trial Details
NCT Number NCT07429214
Lead Sponsor Biosense Webster, Inc.
Conditions Atrial Fibrillation
Enrollment 50 participants
Start Date 2026-03-23
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-13