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PERSIGMA RCTNCT07523750

A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation

StatusRecruiting
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. Trial sites expanded: 10 → 20 locations
  2. Trial sites reduced: 30 → 10 locations
    • Eligibility criteria expanded, about 74 words
    • Secondary endpoints: details revised at 1 of 1 entry
  3. Primary endpoint(s) modified
    • Study sites: 29 to 30
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 1 entry
    v6
  4. Enrollment increased: 466 → 566 participants
    • Trial sites expanded: 11 → 29 locations
    v5
  5. Trial sites expanded: 1 → 11 locationsv4
  6. Start date changed from estimate of Apr 6, 2026 to Apr 2, 2026v3
  7. Recruitment opened
    • Site details revised
    v2
  8. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Occurrence of Early Onset Primary Adverse Events (PAEs)
Timeframe: Up to 7 days post-index procedure
Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Timeframe: Day 61 and onward

Secondary (1)

Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score

Arms and interventions

VARIPULSE Pulsed Field Ablation (PFA) CatheterExperimental

Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation will undergo the ablation procedure with VARIPULSE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an magnetic resonance imaging (MRI) subset and undergo MRI assessments at baseline and post-ablation procedure.

FARAWAVE PFA CatheterActive comparator

Participants with PsAF undergoing catheter ablation will undergo the ablation procedure with FARAWAVE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an MRI subset and undergo MRI assessments at baseline and post-ablation procedure.

Devices: VARIPULSE Catheter, FARAWAVE Catheter

Sites

20 sites in 1 country