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NCT06578104

PULSED AF Post-Approval Study

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 15 versions: 14 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 23 → 29 locations
  2. Site details revised at 2 of 23 sites
  3. Eligibility criteria expanded, about 10 words
    • Primary endpoints: details revised at 1 of 2 entries
    • Site details revised at 2 of 23 sites
  4. Trial sites expanded: 18 → 23 locationsv12
  5. Primary completion pushed from Jun 1, 2026 to Apr 30, 2027
    • Study completion pushed from Jun 1, 2029 to Apr 30, 2030
    v11
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 16 to 18v10
  2. Site details revised at 1 of 16 sitesv9
  3. Study sites: 14 to 16v8
  4. Eligibility criteria expanded, about 4 words
    • Study sites: 11 to 14
    v7
  5. Study sites: 8 to 11v5
  6. Study sites: 2 to 8v4
  7. Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure to Medtronic Cardiac Ablation Solutions
    • Site contacts updated at 1 of 2 sites
    v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Dec 1, 2024 to Nov 4, 2024
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Efficacy-Freedom from Atrial Fibrillation
Timeframe: 36-months after the index ablation procedure
Safety- Freedom from Device/Procedure Related Adverse Events
Timeframe: 6 months post-ablation]

Arms and interventions

Paroxysmal

Ablation using the PulseSelect™ PFA system

Persistent

Ablation using the PulseSelect™ PFA system

Devices: PulseSelect™ PFA system

Sites

29 sites in 3 countries

United States 21, Canada 6, South Korea 2