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GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

Study acronym: REDUCE PAS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 45 sitesv38
  2. Study sites: 44 to 45v37
  3. Study sites: 41 to 44v36
  4. Primary completion date: Dec 2026 to Oct 2028
    • Study completion date: Dec 2029 to Oct 2031
    • Study sites revised (41)
    v35
  5. Study sites: 40 to 41v34
Show 32 earlier versionsHide 32 earlier versions
  1. Site details revised at 3 of 40 sitesv33
  2. Study sites: 39 to 40v32
  3. Study sites: 40 to 39v31
  4. Re-verified, no change to tracked fieldsv30
  5. Study sites: 39 to 40v29
  6. Study sites revised (39)v28
  7. Study sites: 36 to 39v27
  8. 3 versions Re-verified since Jun 2, 2021, no change to tracked fieldsv24-v26
  9. Study sites: 37 to 36v23
  10. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 2028 to Dec 2029
    v22
  11. 3 versions Re-verified since Jan 6, 2021, no change to tracked fieldsv19-v21
  12. Site details revised at 1 of 37 sitesv18
  13. Site details revised at 1 of 37 sitesv17
  14. 2 versions Re-verified since Aug 31, 2020, no change to tracked fieldsv15-v16
  15. Site details revised at 2 of 37 sitesv14
  16. Re-verified, no change to tracked fieldsv13
  17. Study sites: 36 to 37v12
  18. Study sites: 37 to 36v11
  19. Site details revised at 4 of 37 sitesv10
  20. Study sites: 38 to 37v9
  21. Site details revised at 11 of 38 sitesv8
  22. Study sites: 37 to 38
    • Start date changed from estimate of Aug 2019 to Jul 25, 2019
    v7
  23. Start date: Jun 2019 to Aug 2019
    • Study sites: 38 to 37
    v6
  24. Start date: May 2019 to Jun 2019v5
  25. Study sites: 4 to 38v4
  26. Study sites: 3 to 4
    • Start date: Apr 2019 to May 2019
    v3
  27. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
W.L.Gore & Associates
43 trials monitored
See 2 trials at risk
Heart Disease
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Stroke
3,531 trials monitored
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This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
Trial Details
NCT Number NCT03821129
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Stroke, PFO - Patent Foramen Ovale
Related terms Foramen Ovale, Patent, Stroke
Enrollment 636 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov