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Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 19 to 32v35
  2. Results first posted: Nov 24, 2025v34 Show 7 more changesShow less
    • Enrollment target: 33 to 128
    • Primary endpoint revised
    • Study sites: 17 to 19
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 2 to 9
    • Study description expanded, about 1 word
    • Collaborators shortened, about 1 word
  3. 7 versions Re-verified since Oct 13, 2023, no change to tracked fieldsv27-v33
  4. Enrollment target: estimated 110 to confirmed 33
    • Study completion date: Jul 2027 to Dec 2028
    • Interventions: Twelve TMVR Implant (Device) to Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System (Device), Twelve TMVR Implant (Device)
    • Study title expanded, about 3 words
    v26
  5. Study sites: 21 to 17v25
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 23 to 21v24
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 26 to 23
    • Primary completion date changed from estimate of Feb 2023 to Sep 1, 2022
    v23
  3. Primary completion date: Dec 2022 to Feb 2023v22
  4. Site details revised at 2 of 26 sitesv21
  5. Primary completion date: Jul 2022 to Dec 2022
    • Site details revised at 1 of 26 sites
    • Study description expanded, about 1 word
    v20
  6. Study sites: 28 to 26v19
  7. Primary completion date: Dec 2021 to Jul 2022
    • Study completion date: Dec 2024 to Jul 2027
    v18
  8. Lead sponsor: [Redacted] to Medtronic Cardiovascularv17 Show 6 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Dec 2021
    • Study completion date: Dec 2024
    • Start date: Apr 2015
    • Collaborators expanded, about 1 word
    • Study title expanded, about 2 words
  9. 15 versions Re-verified since Apr 21, 2015, no change to tracked fieldsv2-v16
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation
Trial Details
NCT Number NCT02322840
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Mitral Valve Insufficiency
Related terms Mitral Valve Insufficiency
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov