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Harmony TPV Post-Approval Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 2026 → Nov 2026
See other at-risk trials from Medtronic Cardiovascular

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2026 to Nov 2026
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 10 of 20 sites
    • Publications: details revised at 1 of 1 entry
  2. Enrollment increased: 150 → 174 participantsv30
  3. Re-verified, no change to tracked fieldsv29
  4. Primary completion date: Oct 2025 to Aug 2026v28
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 22 to 20
    v27
Show 25 earlier versionsHide 25 earlier versions
  1. Site details revised at 1 of 22 sitesv26
  2. Study sites: 21 to 22v25
  3. Site details revised at 1 of 21 sitesv24
  4. Site details revised at 1 of 21 sitesv23
  5. Study sites: 20 to 21v22
  6. Site details revised at 1 of 20 sitesv21
  7. Study sites: 19 to 20v20
  8. Eligibility criteria shortened, about 43 wordsv19
  9. Site details revised at 1 of 19 sitesv18
  10. Site contacts updated at 1 of 19 sitesv17
  11. Site details revised at 1 of 19 sitesv16
  12. Study sites: 18 to 19v15
  13. Study sites: 17 to 18v14
  14. Primary completion date: Sep 2023 to Oct 2025
    • Study completion date: Mar 2033 to Mar 2035
    v13
  15. Study sites: 15 to 17v12
  16. Site details revised at 1 of 15 sitesv11
  17. Study sites: 14 to 15v10
  18. Study sites: 12 to 14v9
  19. Primary completion date: Oct 2024 to Sep 2023
    • Study completion date: May 2034 to Mar 2033
    • Site details revised at 1 of 12 sites
    v8
  20. Primary endpoint revised
    • Study sites: 11 to 12
    • Secondary endpoints revised (6)
    v7
  21. Study sites: 9 to 11v6
  22. Study sites: 8 to 9v5
  23. Study sites: 2 to 8v4
  24. Study sites: 1 to 2v3
  25. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2021 to Oct 25, 2021
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
Trial Details
NCT Number NCT05077774
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
Related terms Heart Defects, Congenital, Pulmonary Valve Insufficiency, Tetralogy of Fallot
Enrollment 174 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov