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Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Study acronym: APOLLO-EU
StatusRecruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Site contacts updated at 11 of 37 sitesv41
  2. Site contacts updated at 1 of 37 sitesv40
  3. Study sites: 36 to 37v39
  4. Study sites: 35 to 36v38
  5. Study sites: 34 to 35v37
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites: 33 to 34v36
  2. Study sites: 32 to 33v35
  3. Study sites: 31 to 32v34
  4. Study sites: 30 to 31v33
  5. Site contacts updated at 1 of 30 sitesv32
  6. Study sites: 29 to 30v31
  7. Study sites: 25 to 29v30
  8. Study sites: 24 to 25v29
  9. Site details revised at 8 of 24 sitesv28
  10. Site details revised at 8 of 24 sitesv27
  11. Study sites: 23 to 24v26
  12. Primary completion date: Nov 2026 to Aug 2029v25 Show 4 more changesShow less
    • Enrollment target: 360 to 400
    • Study completion date: Mar 2032 to Dec 2038
    • Start date: Jan 13, 2023 to Feb 7, 2023
    • Eligibility criteria expanded, about 16 words
  13. Study sites: 22 to 23v24
  14. Study sites: 21 to 22v23
  15. Study sites: 20 to 21v22
  16. Study sites: 19 to 20v21
  17. Study sites: 17 to 19v20
  18. Study sites: 15 to 17v19
  19. Study sites: 14 to 15v18
  20. Study sites: 13 to 14v17
  21. Study sites: 12 to 13v16
  22. Study sites: 11 to 12v15
  23. Study sites: 9 to 11v14
  24. Study sites: 8 to 9v13
  25. Study sites: 7 to 8v12
  26. Study sites: 6 to 7v11
  27. Study sites: 5 to 6v10
  28. Study sites: 4 to 5v9
  29. Study sites: 3 to 4v8
  30. Study sites: 1 to 3v7
  31. Start date: Dec 22, 2022 to Jan 13, 2023v6
  32. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2023 to Dec 22, 2022
    v5
  33. Start date: Nov 2022 to Jan 2023v4
  34. Eligibility criteria expanded, about 26 wordsv3
  35. Eligibility criteria shortened, about 518 words
    • Secondary endpoints revised (9)
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
Trial Details
NCT Number NCT05496998
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Mitral Regurgitation
Related terms Gastroesophageal Reflux, Lymphoma, Follicular, Mitral Valve Insufficiency
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov