Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

NCT05526560 · tracked via the Priya Life Science UK tracker

Sponsor

Edwards Lifesciences

Phase

Observational

Started

2023-01-11

Last updated

2026-05-22

Condition(s) studied

Mitral StenosisMitral Valve Insufficiency

Investigational drug(s) / intervention(s)

MITRIS RESILIA Mitral Valve, Model 11400M

MITRIS RESILIA Mitral Valve, Model 11400M: Replacement of mitral valve with MITRIS RESLIA Mitral Valve

Study summary

Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 18 years or older at the time of informed consent * Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery * Provides written informed consent * Willingness to follow protocol requirements Exclusion Criteria: * Active endocarditis 3 months prior to the procedure * Stage 4 renal disease or requiring dialysis * Less than 2-year life expectancy due to non-cardiovascular life-threatening disease * High predicted risk of mortality prior to procedure * Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of \> 8 or * Surgeon estimated risk of mortality of \> 8

Primary outcome measure(s)

Freedom from valve related death or valve related reintervention — 1 year
Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee
Hemodynamic performance as measured by peak and mean gradient by echocardiography — 1 year
Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation

Trial sites (34)

Facility	City	Region
Hoag Memorial Hospital Presbyterian	Newport Beach	California
Stanford University	Palo Alto	California
AdventHealth Orlando	Orlando	Florida
Piedmont Heart Institute	Athens	Georgia
Piedmont Heart Institute	Atlanta	Georgia
Ascension St. Vincent Heart Center	Carmel	Indiana
University of Michigan	Ann Arbor	Michigan
Mayo Clinic, Rochester	Rochester	Minnesota
Washington University Barnes-Jewish Hospital	St Louis	Missouri
Mount Sinai Hospital	New York	New York
Columbia University Irving Medical Center	New York	New York
Weill Cornell Medicine	New York	New York
Duke University Medical Center	Durham	North Carolina
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
Allegheny General Hospital	Pittsburgh	Pennsylvania
UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania
Tristar Centennial Medical Center	Nashville	Tennessee
Ascension Saint Thomas	Nashville	Tennessee
University of Utah	Salt Lake City	Utah
Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
St. Paul's Hospital and Vancouver General Hospital	Vancouver	British Columbia
London Health Sciences Centre, University Hospital (LHSC)	London	Ontario
Montreal Heart Institute	Montreal	Quebec
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval	Québec	Canada
Universitätsklinikum Augsburg	Augsburg	Germany
Rhoen-Klinikum Campus Bad Neustadt	Bad Neustadt an der Saale	Germany
Herz- und Diabeteszentrum NRW	Bad Oeynhausen	Germany
University Clinic Bonn	Bonn	Germany
Klinikum Links der Weser	Bremen	Germany
Deutsches Herzzentrum München	München	Germany
Royal Papworth Hospital	Cambridge	United Kingdom
St. Thomas Hospital	London	United Kingdom
King's College Hospital	London	United Kingdom
Cleveland Clinic London	London	United Kingdom

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 NCT05526560 on ClinicalTrials.gov ↗ ← All trials in the UK