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

NCT02322840 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-01-14

Study results available
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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

Conditions

  • Mitral Valve Insufficiency

Interventions

DEVICE

Twelve TMVR Implant

Implantation of the Twelve TMVR System - Apical

DEVICE

Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System

Implantation of the Medtronic Intrepid™ Transcatheter Mitral Valve- Transfemoral

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Lynnett Stahl · Medtronic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2022-09-01
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Denmark
  • Finland
  • France
  • Greece
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02322840 on ClinicalTrials.gov