NCT02322840

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

PILOT: The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of The Intrepid™ TMVR System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery. EFS: The study is a multi-center, prospective, non-randomized, trial 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

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2022-09-01
• Completion: 2028-12-01
• First posted: 2014-12-23
• Last updated: 2026-01-14
• Results posted: 2025-11-24

Locations

32 sites across 7 countries: United States, Australia, Denmark, Finland, France, Greece, United Kingdom

Regulatory

• FDA-regulated device study