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TTVR Early Feasibility Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 42 days later Jul 30, 2026 → Sep 10, 2026
See other at-risk trials from Medtronic Cardiovascular

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Sep 10, 2026 to Aug 31, 2026
  2. Eligibility criteria expanded, about 16 words
    • Site details revised at 1 of 20 sites
  3. Enrollment closed, study ongoing
    • Primary completion pushed from Jul 30, 2026 to Sep 10, 2026
    • Study completion date: Jul 30, 2031 to Aug 26, 2031
    • Site details revised at 20 of 20 sites
    v18
  4. Site details revised at 1 of 20 sitesv17
  5. Site contacts updated at 2 of 20 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites revised (20)v15
  2. Primary completion date: Jul 30, 2025 to Jul 30, 2026
    • Site details revised at 2 of 20 sites
    v14
  3. Site details revised at 2 of 20 sitesv13
  4. Enrollment target: 15 to 150
    • Study sites: 15 to 20
    v12
  5. Primary completion date: Sep 30, 2024 to Jul 30, 2025
    • Study sites: 14 to 15
    • Study completion date: Apr 30, 2031 to Jul 30, 2031
    v11
  6. Primary completion date: Aug 28, 2023 to Sep 30, 2024
    • Study completion date: Nov 15, 2026 to Apr 30, 2031
    v10
  7. Primary completion date: Apr 28, 2023 to Aug 28, 2023v9
  8. Primary completion date: Oct 28, 2022 to Apr 28, 2023
    • Study sites: 13 to 14
    v8
  9. Re-verified, no change to tracked fieldsv7
  10. Primary completion date: Oct 31, 2021 to Oct 28, 2022v6
  11. Study sites: 5 to 13
    • Eligibility criteria shortened, about 375 words
    v5
  12. Site details revised at 1 of 5 sitesv4
  13. Study sites: 1 to 5v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 15, 2020 to Oct 20, 2020
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Trial Details
NCT Number NCT04433065
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Tricuspid Regurgitation
Related terms Tricuspid Valve Insufficiency
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov