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 Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

PILOT:

The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in very high risk mitral regurgitation patients.

EFS:

The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with 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 trial to evaluate the safety and performance of the Twelve TMVR System in very high-risk patients with severe, symptomatic mitral regurgitation, who are deemed ineligible for standard 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): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • Royal Prince Alfred Hospital
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• France
  • Lille, France
    • Centre Hospitalier Universitaire
• United Kingdom
  • London, United Kingdom
    • St. Thomas' Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Abrazo Arizon Heart Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
  • Illinois
    • Chicago, Illinois, United States, 60208
      • Northwestern University
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Hospitals
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10029
      • Mt. Sinai Medical Center
    • New York, New York, United States, 10032
      • Columbia
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences University Hospital
  • Pennsylvania
    • Wormleysburg, Pennsylvania, United States, 17043
      • UPMC Pinnacle Harrisburg
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's

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 (MR Grade 3-4+)
• Symptomatic mitral regurgitation (NYHA Class II-IV)
• Trans-apical access deemed feasible by the treating physician (PILOT only)
• 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 Twelve TMVR/Intrepid

Key Exclusion Criteria:

• Left ventricular ejection fraction (LVEF) < 20 (PILOT) or <25% (EFS)
• Evidence of intracardiac mass, thrombus, or vegetation
• Prior valve surgery or need for other valve surgery
• Prior stroke within 4 weeks (PILOT) or 90 days (EFS)
• Prior myocardial infarction within 6 months (PILOT) or 90 days (EFS)
• Need for coronary revascularization
• History of, or active, endocarditis
• Renal insufficiency (Creatinine > 2.5 mg/dL)

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; Implant of Intrepid 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
Adverse Events	Number of patients with adverse events associated with the delivery and/or implantation of the device	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success (Number of patients with successful TMVR placement)	Number of patients with successful TMVR placement	Through 5 years
Reduction of MR (Number of patients with a reduction of MR Grade)	Number of patients with a reduction of MR Grade	Through 5 years

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.

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 (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 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