Clinical Trial

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

Active, Not Recruiting
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Summary
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
Protocol Amendment History 34 amendments
This ClinicalTrials.gov record has been amended 34 times since 2014-12-22; most recent amendment 2025-12-19.
Status change: Recruiting → Active, Not Recruiting 2023-03-20
Status change: Withheld → Recruiting 2021-10-29
Trial Details
NCT Number NCT02322840
Lead Sponsor Medtronic Cardiovascular
Conditions Mitral Valve Insufficiency
Enrollment 128 participants
Start Date 2015-04
Primary Completion 2022-09-01 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-14