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

Study acronym: SPAA PFA
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Trial sites expanded: 3 → 11 locations
    • Start date changed from estimate of Aug 24, 2026 to Aug 26, 2026
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Trial sites reduced: 27 → 3 locations
    • Study completion date: Aug 4, 2031 to Aug 24, 2031
    • Start date: Aug 5, 2026 to Aug 24, 2026
    v5
  3. Enrollment increased: 920 → 1070 participants
    • Trial sites expanded: 19 → 27 locations
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 1 of 2 entries
    v4
  4. Recruitment opened
    • Start date: May 29, 2026 to Aug 5, 2026
    • Trial sites expanded: 3 → 19 locations
    • Study completion pushed from May 23, 2031 to Aug 4, 2031
    v3
  5. Trial sites expanded: 0 → 3 locationsv2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07527299
Lead Sponsor Biosense Webster, Inc.
Conditions
(from sponsor)		 Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 1,070 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov