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
1 other identifier
interventional
128
7 countries
32
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedResults Posted
Study results publicly available
November 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
ExpectedJanuary 14, 2026
December 1, 2025
7.4 years
October 31, 2014
August 26, 2025
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Number of Subjects With Procedural Success
Procedure
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days
30 days
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days
Through 30 Days
Change in New York Heart Association (NYHA) From Baseline Through 30 Days
Through 30 days
Change in New York Heart Association (NYHA) From Baseline Through 30 Days
Through 30 Days
- +4 more secondary outcomes
Study Arms (1)
Transcatheter Mitral Valve Replacement (TMVR) Implant
EXPERIMENTALTwelve TMVR Implant
Interventions
Implantation of the Twelve TMVR System - Apical
Implantation of the Medtronic Intrepid™ Transcatheter Mitral Valve- Transfemoral
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Abrazo Arizona Heart Hospital - EFS
Phoenix, Arizona, 85016, United States
Cedars-Sinai Medical Center - PILOT
Los Angeles, California, 90048, United States
Piedmont Atlanta Hospital - PILOT
Atlanta, Georgia, 30309, United States
Northwestern Memorial Hospital - PILOT
Chicago, Illinois, 60208, United States
University of Michigan Health System - University Hospital - PILOT
Ann Arbor, Michigan, 48109, United States
Corewell Health - EFS
Grand Rapids, Michigan, 49503, United States
Abbott Northwestern Hospital - EFS
Minneapolis, Minnesota, 55407, United States
Abbott Northwestern Hospital - PILOT
Minneapolis, Minnesota, 55407, United States
Barnes Jewish Hospital - PILOT
St Louis, Missouri, 63110, United States
NYU Langone Medical Center - PILOT
New York, New York, 10016, United States
The Mount Sinai Hospital (New York NY) - EFS
New York, New York, 10029, United States
The Mount Sinai Hospital (New York NY) - PILOT
New York, New York, 10029, United States
New York-Presbyterian Hospital Columbia University Medical Center - EFS
New York, New York, 10032, United States
New York-Presbyterian Hospital Columbia University Medical Center - PILOT
New York, New York, 10032, United States
Oregon Health & Science University Hospital - EFS
Portland, Oregon, 97239, United States
UPMC Pinnacle Harrisburg Campus - EFS
Wormleysburg, Pennsylvania, 17043, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT
Dallas, Texas, 75246, United States
Houston Methodist Hospital - PILOT
Houston, Texas, 77030, United States
University of Virginia Medical Center - EFS
Charlottesville, Virginia, 22908, United States
Aurora Saint Luke's Medical Center - EFS
Milwaukee, Wisconsin, 53215, United States
Aurora Saint Lukes Medical Center - PILOT
Milwaukee, Wisconsin, 53215, United States
Monash Health - PILOT
Clayton, Victoria, 3168, Australia
The Alfred Hospital - PILOT
Melbourne, Australia
Royal Prince Alfred Hospital - PILOT
Sydney, Australia
Rigshospitalet - PILOT
Copenhagen, Denmark
Helsinki University Hospital - PILOT
Helsinki, FL-00029 HUS, Finland
Centre Hospitalier Régional Universitaire de Lille - PILOT
Lille, France
Clinique Pasteur - PILOT
Toulouse, France
Hygeia Hospital - PILOT
Athens, Greece
Royal Sussex County Hospital - PILOT
Brighton, United Kingdom
The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary - PILOT
Leeds, LS1 3EX, United Kingdom
Guys & St Thomas NHS Foundation Trust - St Thomas Hospital - PILOT
London, United Kingdom
Related Publications (3)
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. 2026 Feb 2;22(3):e172-e182. doi: 10.4244/EIJ-D-25-01133.
PMID: 41251714DERIVEDZahr 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.
PMID: 34747699DERIVEDBapat 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.
PMID: 29102689DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
NCT02322840 covers the PILOT study and the Early Feasibility Study (EFS)
Results Point of Contact
- Title
- Yetunde Ishola (Clinical Study Manager)
- Organization
- Medtronic
Study Officials
- STUDY DIRECTOR
Lynnett Stahl
Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2014
First Posted
December 23, 2014
Study Start
April 1, 2015
Primary Completion
September 1, 2022
Study Completion (Estimated)
December 1, 2028
Last Updated
January 14, 2026
Results First Posted
November 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share