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Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

Study acronym: PRIMARY
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Nov 15, 2028 → Jun 30, 2029
See other at-risk trials from Annetine Gelijns

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 62 → 67 locations
    • Study completion pushed from Jan 1, 2034 to Jan 31, 2034
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 10 of 27 entries
  2. Primary completion pushed from Nov 15, 2028 to Jun 30, 2029
    • Study completion pushed from Nov 15, 2030 to Jan 1, 2034
    v35
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Study sites: 61 to 62
    v34
  4. 2 versions Re-verified since Feb 12, 2026, no change to tracked fieldsv32-v33
  5. Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 8 of 27 entries
    • Study sites revised (61)
    v31
Show 29 earlier versionsHide 29 earlier versions
  1. Study sites: 58 to 61v30
  2. Primary endpoint revisedv29 Show 4 more changesShow less
    • Study sites: 41 to 58
    • Eligibility criteria revised
    • Secondary endpoints: 26 to 27
    • Study description expanded, about 10 words
  3. Site contacts updated at 1 of 41 sitesv28
  4. Primary completion date: Jan 2028 to Nov 15, 2028
    • Study completion date: Jan 2032 to Nov 15, 2030
    v27
  5. Site contacts updated at 7 of 41 sitesv26
  6. Study sites: 28 to 41
    • Study title expanded, about 7 words
    v25
  7. Re-verified, no change to tracked fieldsv24
  8. Study sites: 27 to 28
    • Eligibility criteria expanded, about 11 words
    v23
  9. Site contacts updated at 1 of 27 sitesv22
  10. Secondary endpoints: details revised at 24 of 26 entries
    • Study description shortened, about 37 words
    • Site details revised at 1 of 27 sites
    v21
  11. Start date: Jan 14, 2022 to Feb 21, 2022
    • Study sites: 26 to 27
    v20
  12. Site details revised at 1 of 26 sitesv19
  13. Site details revised at 2 of 26 sitesv18
  14. Study sites: 23 to 26v17
  15. Site details revised at 1 of 23 sitesv16
  16. Study sites: 22 to 23v15
  17. Study sites: 21 to 22v14
  18. Site details revised at 1 of 21 sitesv13
  19. Study sites revised (21)v12
  20. Study sites: 20 to 21v11
  21. Site details revised at 1 of 20 sitesv10
  22. Site details revised at 1 of 20 sitesv9
  23. Site details revised at 1 of 20 sitesv8
  24. Site details revised at 1 of 20 sitesv7
  25. Site details revised at 2 of 20 sitesv6
  26. Site details revised at 1 of 20 sitesv5
  27. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Dec 2027 to Jan 2028
    • Study completion date: Dec 2031 to Jan 2032
    • Start date changed from estimate of Dec 2021 to Jan 14, 2022
    • Site details revised at 20 of 20 sites
  28. Primary completion date: Oct 2027 to Dec 2027
    • Study completion date: Oct 2031 to Dec 2031
    • Start date: Nov 2021 to Dec 2021
    • Study sites revised (20)
    v3
  29. Start date: Oct 1, 2021 to Nov 2021
    • Primary completion date: Oct 1, 2027 to Oct 2027
    • Study completion date: Oct 1, 2031 to Oct 2031
    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.
Annetine Gelijns
2 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.
Trial Details
NCT Number NCT05051033
Lead Sponsor Annetine Gelijns
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Mitral Valve Regurgitation
Related terms Mitral Valve Insufficiency
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov