Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

NCT03242642 · tracked via the Priya Life Science USA tracker

Sponsor

Medtronic Cardiovascular

Phase

N/A

Started

2017-10-23

Last updated

2026-09-15

Condition(s) studied

Mitral Valve Regurgitation

Investigational drug(s) / intervention(s)

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR): mitral valve replacement

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR): Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement

Study summary

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Moderate to severe or severe symptomatic mitral regurgitation * Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention Exclusion Criteria: * prior transcatheter mitral valve procedure with device currently implanted * anatomic contraindications * prohibitive mitral annular calcification * left ventricular ejection fraction \<25% * need for emergent or urgent surgery * hemodynamic instability

Primary outcome measure(s)

Primary Cohort — 1 year
Composite of all-cause mortality or heart failure hospitalization
MAC Cohort — 1 year
All-cause mortality

Trial sites (85)

Facility	City	Region	Status
University of Alabama Birmingham (UAB) Hospital	Birmingham	Alabama	Recruiting
Abrazo Heart Hospital	Phoenix	Arizona	Recruiting
Scripps Memorial Hospital	La Jolla	California	Recruiting
PIH Health Good Samaritan Hospital	Los Angeles	California	Recruiting
Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	Recruiting
Keck Hospital of the University of Southern California, USC	Los Angeles	California	Recruiting
Cedars Sinai Medical Center	Los Angeles	California	Recruiting
El Camino Hospital	Mountain View	California	Recruiting
Kaiser Permanente San Francisco Medical Center	San Francisco	California	Recruiting
Stanford Hospital and Clinics	Stanford	California	Recruiting
Los Robles Regional Medical Center	Thousand Oaks	California	Recruiting
Hartford Hospital	Hartford	Connecticut	Recruiting
Yale New Haven Hospital	New Haven	Connecticut	Recruiting
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	Recruiting
JFK Medical Center	Atlantis	Florida	Recruiting
Morton Plant	Clearwater	Florida	Recruiting
HealthPark Medical Center	Fort Myers	Florida	Recruiting
North Florida Regional Medical Center	Gainesville	Florida	Recruiting
Baptist Medical Center Jacksonville	Jacksonville	Florida	Recruiting
University of South Florida Health	Tampa	Florida	Recruiting
Emory University	Atlanta	Georgia	Recruiting
Piedmont Atlanta Hospital	Atlanta	Georgia	Recruiting
Northwestern Memorial Hospital	Chicago	Illinois	Recruiting
Rush University Medical Center	Chicago	Illinois	Recruiting
MercyOne Des Moines Medical Center	Des Moines	Iowa	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Recruiting
University of Maryland Medical Center	Baltimore	Maryland	Completed
The Johns Hopkins Hospital	Baltimore	Maryland	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
University of Michigan Health System	Ann Arbor	Michigan	Recruiting
Henry Ford Saint John Hospital	Detroit	Michigan	Recruiting
Corewell Health	Grand Rapids	Michigan	Recruiting
Abbott Northwestern Hospital	Minneapolis	Minnesota	Recruiting
M Health Fairview University of Minnesota Medical Center - East Bank	Minneapolis	Minnesota	Active Not Recruiting
Barnes-Jewish Hospital	St Louis	Missouri	Recruiting
Providence St Patrick	Missoula	Montana	Recruiting
Morristown Medical Center	Morristown	New Jersey	Recruiting
Jersey Shore University Medical Center	Neptune City	New Jersey	Recruiting

+ 45 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03242642 on ClinicalTrials.gov ↗ ← All trials in the USA