Clinical Trial

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

Active, Not Recruiting
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Summary
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
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2018-08-13; most recent amendment 2026-04-22.
Status change: Recruiting → Active, Not Recruiting 2019-10-28
Status change: Not Yet Recruiting → Recruiting 2018-12-21
Trial Details
NCT Number NCT03635424
Lead Sponsor Medtronic Cardiovascular
Conditions Bicuspid Aortic Valve
Enrollment 150 participants
Start Date 2018-10-30
Primary Completion 2019-11-13 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-05