Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Running, not enrolling

Conditions studied: Mitral Stenosis, Mitral Valve Insufficiency

In brief

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.

Key facts

Study ID

NCT05526560

Run by

Edwards Lifesciences

People needed

504

Starts

2023-01-11

Expected to finish

2035-12-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Stanford University — Palo Alto, California, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Piedmont Heart Institute — Athens, Georgia, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Ascension St. Vincent Heart Center — Carmel, Indiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• Washington University Barnes-Jewish Hospital — St Louis, Missouri, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• UPMC Presbyterian Shadyside — Pittsburgh, Pennsylvania, United States
• Tristar Centennial Medical Center — Nashville, Tennessee, United States
• Ascension Saint Thomas — Nashville, Tennessee, United States
• University of Utah — Salt Lake City, Utah, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• St. Paul's Hospital and Vancouver General Hospital — Vancouver, British Columbia, Canada
• London Health Sciences Centre, University Hospital (LHSC) — London, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Canada
• Universitätsklinikum Augsburg — Augsburg, Germany

Full record on ClinicalTrials.gov

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