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VP-EXTRANCT07428564

A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF

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

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Final enrollment: 42 participants (planned 50)
    • Site details revised at 6 of 6 sites
  2. Study sites: 5 to 6
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 5 of 12 entries
  3. Trial sites reduced: 10 → 5 locationsv6
  4. Primary endpoint(s) modified
    • Secondary endpoints: 5 to 12
    • Eligibility criteria expanded, about 4 words
    v5
  5. Site details revised at 2 of 10 sitesv4
  6. Recruitment opened
    • Start date changed from estimate of Mar 1, 2026 to May 19, 2026
    • Study sites revised (10)
    v3
  7. Study sites: 9 to 10
    • Primary and study completion dates: Dec 31, 2026 to Dec 30, 2026
    v2
  8. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Acute Procedural Success
Timeframe: Intraoperative
Pulmonary Vein Isolation (PVI) Durability
Timeframe: Up to 3 months post index ablation procedure
Pulsed Field (PF) Applications Time
Timeframe: Intraoperative
Number of PF applications
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
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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 Magnetic Resonance Imaging (MRI) Evaluations
Occurrence of New or Worsening Neurological Deficits
Mini Mental State Examination (MMSE) Total Score
National Institutes of Health Stroke Scale (NIHSS) Score
Modified Rankin Scale (mRS) Scale Score
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) 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