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NCT05227053

STOP AF First Post-Approval Study

StatusCompleted
PhaseNot specified
Primary completion
Track this trial

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Record History

All 21 versions: 21 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Final enrollment: 142 participants (planned 200)
    • Primary and study completion dates changed from estimate of Oct 2026 to Sep 18, 2026
  2. Primary and study completion moved earlier from Apr 2028 to Oct 2026 Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Enrollment closed, study ongoing
    • Study sites: 13 to 11
    • Eligibility criteria expanded, about 10 words
  3. Site contacts updated at 9 of 13 sitesv19
  4. Site details revised at 2 of 13 sitesv18
  5. Primary and study completion dates: Jan 2028 to Apr 2028v17
Show 15 earlier versionsHide 15 earlier versions
  1. Site contacts updated at 4 of 13 sitesv16
  2. Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure to Medtronic Cardiac Ablation Solutionsv15
  3. Eligibility criteria expanded, about 56 wordsv14
  4. Site details revised at 1 of 13 sitesv13
  5. Study sites: 12 to 13v12
  6. Study sites: 11 to 12v11
  7. Study sites: 10 to 11v10
  8. Study sites: 9 to 10v9
  9. Study sites: 6 to 9v8
  10. Primary and study completion dates: Feb 2026 to Jan 2028v7
  11. Study sites: 4 to 6v6
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Apr 2022 to Apr 28, 2022
    v5
  13. Start date: Mar 2022 to Apr 2022v4
  14. Start date: Feb 2022 to Mar 2022v3
  15. Study description shortened, about 2 wordsv2
  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

Sites

11 sites in 1 country