Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
NCT ID: NCT05526560
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
504 participants
OBSERVATIONAL
2023-01-11
2035-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients requiring replacement of their native or prosthetic mitral valve
Patients requiring replacement of their native or prosthetic mitral valve
MITRIS RESILIA Mitral Valve, Model 11400M
Replacement of mitral valve with MITRIS RESLIA Mitral Valve
Interventions
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MITRIS RESILIA Mitral Valve, Model 11400M
Replacement of mitral valve with MITRIS RESLIA Mitral Valve
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gorav Ailawadi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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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
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
Countries
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Other Identifiers
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2022-09
Identifier Type: -
Identifier Source: org_study_id
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