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VP-CONFIRMNCT07429214

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

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 10 versions: 6 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Enrollment reduced: 50 → 42 participants
    • Site details revised at 6 of 6 sites
  2. Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 5 of 12 entries
  3. Trial sites reduced: 10 → 6 locationsv7
  4. Primary endpoint(s) modified
    • Secondary endpoints: 5 to 12
    • Site details revised at 3 of 10 sites
    • Eligibility criteria expanded, about 4 words
    v6
  5. Phase changed: Not specified → Not applicablev3 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Sponsor changed: [Redacted] to Biosense Webster, Inc.
    • Trial status changed: Withheld → Recruiting
    • Enrollment changed: None → 50
    • Trial sites expanded: 0 → 10 locations
    • Trial arms changed: 0 → 1
    • Primary and study completion dates: Dec 30, 2026
    • Start date: Mar 23, 2026
    • Study title expanded, about 5 words
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Acute Effectiveness
Timeframe: Intraoperative
Pulmonary Vein Isolation (PVI) Durability
Timeframe: At 3 months post index ablation procedure
Pulsed Field (PF) Application Time
Timeframe: Intraoperative
Number of PF applications by PV
Timeframe: Intraoperative
Tissue Proximity Indication (TPI)
Timeframe: Intraoperative

Secondary (12)

Occurrence of Serious Adverse Device Effects (SADE) (Within Seven (7) days) of Index Ablation Procedure) Where the Investigational Devices were Used per Clinical Investigation Plan
Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)
Occurrence of SAEs
Occurrence of Non-Serious Adverse Events (Non-SAEs)
Occurrence of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations
Show 7 moreShow less
Anatomical Location of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations
Size of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations
Occurrence of New or Worsening Neurological Deficits
Mini Mental State Examination (MMSE)
National Institutes of Health Stroke Scale (NIHSS)
Modified Rankin Scale (mRS)
Occurrence of Severe Pulmonary Vein (PV) Stenosis

Arms and interventions

Pulsed Field Ablation: VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro SoftwareExperimental

Participants undergoing cardiac ablation for management of treatment of symptomatic Persistent Atrial Fibrillation (PsAF) or Paroxysmal Atrial Fibrillation (PAF) will undergo pulsed field ablation (PFA) with the VARIPULSE Catheter and the TRUPULSE Generator with the new VARIPULSE Pro software.

Devices: Pulsed Field Ablation System

Sites

6 sites in 5 countries

Belgium 2, Denmark 1, Germany 1, Italy 1, Lithuania 1