CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 128 enrolled
Drug / intervention
Twelve TMVR Implant +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02322840
NCT02322840N/AActive
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An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Intrepid Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

Medtronic Cardiovascular·interventional·Posted Dec 23, 2014·Updated Jan 14, 2026

In Brief

A clinical study evaluating Twelve TMVR Implant and Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System for Mitral Valve Insufficiency. Active but no longer recruiting, targeting 128 participants across 32 sites in 7 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Insufficiency
CountriesAustralia, Denmark, Finland, France, Greece, United Kingdom, United States
Collaborators--

Timeline

N/AActive
201520162017201820192020202120222023202420252026202720282029
First PostedDec 23, 2014
Enrollment StartApr 1, 2015
Primary CompletionSep 1, 2022
Study CompletionDec 1, 2028
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 11.5 years ago

Interventions

Twelve TMVR Implantdevice

Implantation of the Twelve TMVR System - Apical

Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement Systemdevice

Implantation of the Medtronic Intrepid™ Transcatheter Mitral Valve- Transfemoral