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

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 Overview

• Status: Active, not recruiting
• Conditions: Mitral Valve Insufficiency
• Intervention / Treatment: Device: Twelve TMVR Implant; Device: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System

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

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • The Alfred Hospital - PILOT
  • Sydney, Australia
    • Royal Prince Alfred Hospital - PILOT
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health - PILOT
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet - PILOT
• Finland
  • Helsinki, Finland, FL-00029 HUS
    • Helsinki University Hospital - PILOT
• France
  • Lille, France
    • Centre Hospitalier Régional Universitaire de Lille - PILOT
  • Toulouse, France
    • Clinique Pasteur - PILOT
• Greece
  • Athens, Greece
    • Hygeia Hospital - PILOT
• United Kingdom
  • Brighton, United Kingdom
    • Royal Sussex County Hospital - PILOT
  • Leeds, United Kingdom, LS1 3EX
    • The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary - PILOT
  • London, United Kingdom
    • Guys & St Thomas NHS Foundation Trust - St Thomas Hospital - PILOT
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Abrazo Arizona Heart Hospital - EFS
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center - PILOT
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Atlanta Hospital - PILOT
  • Illinois
    • Chicago, Illinois, United States, 60208
      • Northwestern Memorial Hospital - PILOT
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System - University Hospital - PILOT
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health - EFS
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital - EFS
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital - PILOT
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital - PILOT
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center - PILOT
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital (New York NY) - EFS
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital (New York NY) - PILOT
    • New York, New York, United States, 10032
      • New York-Presbyterian Hospital Columbia University Medical Center - EFS
    • New York, New York, United States, 10032
      • New York-Presbyterian Hospital Columbia University Medical Center - PILOT
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University Hospital - EFS
  • Pennsylvania
    • Wormleysburg, Pennsylvania, United States, 17043
      • UPMC Pinnacle Harrisburg Campus - EFS
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital - PILOT
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center - EFS
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center - EFS
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Lukes Medical Center - PILOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Severe mitral regurgitation (PILOT)
• moderate-severe or severe mitral regurgitation (EFS)
• Symptomatic mitral regurgitation (NYHA Class II-IV)
• Deemed to be at high risk for conventional mitral valve surgery by the local heart team (including, at minimum, a cardiac surgeon, interventional cardiologist, and an echocardiologist) (PILOT and EFS)
• Subjects anatomically suitable for the Intrepid TMVR delivery system, including transfemoral and transseptal access (EFS only)
• Native mitral valve geometry and size compatible with the Intrepid™ TMVR (PILOT)

Key Exclusion Criteria:

• Left ventricular ejection fraction (LVEF) < 20 (PILOT) or <30% (EFS)
• Evidence of intracardiac mass, thrombus, or vegetation
• Prior valve surgery or need for other valve surgery
• Prior stroke within 30 days (PILOT) or 90 days (EFS)
• Gastrointestinal bleeding within 6 months (PILOT)
• Prior myocardial infarction 90 days (EFS)
• Need for coronary revascularization
• History of, or active, endocarditis if antibiotics are required (EFS)
• Renal insufficiency; Serum Creatinine > 2.5 mg/dL (PILOT) or Creatinine Clearance <30 cc/min (EFS)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transcatheter Mitral Valve Replacement (TMVR) Implant; Twelve TMVR Implant

Device: Twelve TMVR Implant; Implantation of the Twelve TMVR System - Apical; Other Names: Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System; Device: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System; Implantation of the Medtronic Intrepid™ Transcatheter Mitral Valve- Transfemoral; Other Names: Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects With Adverse Events	PILOT: Site Reported Serious Adverse Events Implant or Delivery Related Through 30-Days EFS: Implant, Delivery or device related serious adverse events through 30 days post procedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Procedural Success	PILOT: Successful access, delivery of implant, and retrieval of the delivery system EFS: Successful access, delivery of implant, and retrieval of the delivery system	Procedure
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days	PILOT: Change in MR Grade from baseline measured by echo through 30 days post-procedure. Measured by Echo 30 days post procedure.	30 days
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days	EFS: Change in MR Grade from Baseline measured by echo through 30 days post-procedure. Measured by Echo 30 days post procedure.	Through 30 Days
Change in New York Heart Association (NYHA) From Baseline Through 30 Days	PILOT: Change in NYHA Class from Baseline through 30 days post-procedure.	Through 30 days
Change in New York Heart Association (NYHA) From Baseline Through 30 Days	EFS: Change in NYHA Class from Baseline through 30 days post procedure	Through 30 Days
Number of Subjects Without Mitral Valve Stenosis	PILOT: No significant mitral Valve (MV) Stenosis measured by echo through 30 days post-procedure EFS: No Significant Mitral Valve (MV) Stenosis measured by echo through 30 days post-procedure	Through 30 days
Number of Subject With Left Ventricle Output Tract (LVOT) Patency	PILOT: LVOT patency measured by echo through 30 days post-procedure.	Through 30 days
Percent of Subject With Left Ventricular Outflow Tract (LVOT) Patency	EFS: Left Ventricular Outflow Tract (LVOT) Patency measured by echo through 30 days post-procedure	30 Days post procedure
Number of Subjects With Greater Than or Equal Moderate (2+) Mitral Regurgitation at 30-days	PILOT: Number of subjects with a core lab-evaluated mitral regurgitation grade greater than or equal to moderate at 30-days	Through 30 days

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Collaborators: Medtronic
• Investigators: Study Director: Lynnett Stahl, Medtronic

Publications and helpful links

General Publications

• Zahr F, Song HK, Chadderdon SM, Gada H, Mumtaz M, Byrne T, Kirshner M, Bajwa T, Weiss E, Kodali S, George I, Heiser J, Merhi WM, Thaden JJ, Zhang A, Lim DS, Reardon MJ, Adams DH, Mack MJ, Leon MB. 30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. JACC Cardiovasc Interv. 2022 Jan 10;15(1):80-89. doi: 10.1016/j.jcin.2021.10.018. Epub 2021 Nov 6.
• Bapat V, Rajagopal V, Meduri C, Farivar RS, Walton A, Duffy SJ, Gooley R, Almeida A, Reardon MJ, Kleiman NS, Spargias K, Pattakos S, Ng MK, Wilson M, Adams DH, Leon M, Mack MJ, Chenoweth S, Sorajja P; Intrepid Global Pilot Study Investigators. Early Experience With New Transcatheter Mitral Valve Replacement. J Am Coll Cardiol. 2018 Jan 2;71(1):12-21. doi: 10.1016/j.jacc.2017.10.061. Epub 2017 Nov 16.
• Tang GHL, Rajagopal V, Sorajja P, Bajwa T, Gooley R, Walton A, Modine T, Ng MK, Williams MR, Zajarias A, Hildick-Smith D, Tchetche D, Spargias K, Rajani R, Bapat VN, De Backer O, Blackman D, McCarthy P, Laine M, Jain R, Martin R, Thaden JJ, Marka NA, Mack M, Adams DH, Leon MB, Reardon MJ. Five-Year Outcomes of the Early-Generation Intrepid Transapical Transcatheter Mitral Valve Replacement System. EuroIntervention. 2025 Nov 16:EIJ-D-25-01133. doi: 10.4244/EIJ-D-25-01133. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): September 1, 2022
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 31, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimated): December 23, 2014

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CIP-1403 & MDT19042TMV002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes