Clinical Trial

A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation

Study acronym: SPAA PFA
Recruiting
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Summary
The purpose of this study is 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). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \[PVI\] and superior vena cava isolation \[SVCI\]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.
Protocol Amendment History 6 changes
notable Enrollment increased: 920 -> 1070 participants 2026-08-01
notable Trial sites expanded: 19 -> 27 locations 2026-08-01
critical Recruitment opened 2026-06-23
notable Trial sites expanded: 3 -> 19 locations 2026-06-23
minor Completion pushed: 2031-05-23 -> 2031-08-04 2026-06-23
notable Trial sites expanded: 0 -> 3 locations 2026-05-09
Trial Details
NCT Number NCT07527299
Lead Sponsor Biosense Webster, Inc.
Conditions Atrial Fibrillation
Enrollment 1,070 participants
Start Date 2026-08-05
Primary Completion 2028-11-30 (estimated)
Study Completion 2031-08-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-31