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NCT05005949

STOP Persistent AF PAS

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

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

Record History

All 17 versions: 13 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion moved earlier from Jul 2028 to Dec 2026 Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Enrollment target: estimated 400 to confirmed 393
    • Eligibility criteria expanded, about 7 words
    • Site details revised at 2 of 17 sites
  2. Primary and study completion dates: Aug 2027 to Jul 2028
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 17 of 17 sites
    v14
  3. Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure to Medtronic Cardiac Ablation Solutionsv12
  4. Site details revised at 2 of 17 sitesv11
  5. Site details revised at 5 of 17 sitesv10
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 16 to 17v9
  2. Study sites: 14 to 16v8
  3. Study sites: 13 to 14v7
  4. Primary and study completion dates: Aug 2025 to Aug 2027v5
  5. Study sites: 9 to 13v4
  6. Study sites: 5 to 9v3
  7. Primary completion date: Aug 2022 to Aug 2025
    • Study sites: 1 to 5
    • Start date changed from estimate of Aug 2021 to Aug 19, 2021
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Timeframe: 36 months
Freedom from Primary Safety Events
Timeframe: 12 months

Arms and interventions

Devices: Arctic Front™ Cardiac Cryoablation Catheter System

Sites

17 sites in 6 countries

United States 10, Germany 3, Austria 1, Italy 1, Poland 1, United Kingdom 1