Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in the USA / NCT03242642
Recruiting Not applicable

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
Not applicable
Started
2017-10-23
Last updated
2026-10-30

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
No
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)

FacilityCityRegionStatus
University of Alabama Birmingham (UAB) Hospital Birmingham Alabama Recruiting
Abrazo Heart Hospital Phoenix Arizona Recruiting
Scripps Memorial Hospital La Jolla California Active Not 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 Active Not 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 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.

More Medtronic Cardiovascular trials in the USA

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial Recruiting
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study Active, not recruiting
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System Active, not recruiting
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation Recruiting
Evolut™ EXPAND TAVR II Pivotal Trial Active, not recruiting

Other trials for the same condition

ATLAS (AltaValve) Pivotal Trial Recruiting
MitraClip REPAIR MR Study Active, not recruiting
MitraClip EXPAND G4 Study Active, not recruiting
PARTNER 3 Trial - Mitral Valve in Valve Active, not recruiting
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