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Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since Oct 16, 2025, no change to tracked fieldsv26-v27
  2. Site details revised at 1 of 25 sitesv25
  3. 8 versions Re-verified since Apr 27, 2022, no change to tracked fieldsv17-v24
  4. Study sites revised (25)v16
  5. Re-verified, no change to tracked fieldsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Results first posted: Dec 21, 2020
    • Primary endpoints revised (2)
    • Secondary endpoints revised (18)
    v14
  2. Primary endpoints revised (2)
    • Secondary endpoints: 16 to 18
    v13
  3. Start date: Dec 20, 2018 to Oct 30, 2018v12
  4. Re-verified, no change to tracked fieldsv11
  5. Primary completion date changed from estimate of Dec 2019 to Nov 13, 2019v10
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 25 of 25 sites
    v9
  7. Site details revised at 1 of 25 sitesv8
  8. Study sites: 24 to 25v7
  9. Eligibility criteria revised
    • Secondary endpoints: 15 to 16
    v6
  10. Study sites: 8 to 24v5
  11. Study sites: 6 to 8v4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Nov 2018 to Dec 20, 2018
    v3
  13. Start date: Sep 2018 to Nov 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
Trial Details
NCT Number NCT03635424
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Bicuspid Aortic Valve
Related terms Bicuspid Aortic Valve Disease
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov