A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama Hospital
WITHDRAWN
Birmingham
California
University of Southern California
WITHDRAWN
Los Angeles
Hoag Memorial Hospital Presbyterian
ACTIVE_NOT_RECRUITING
Newport Beach
Stanford University
ACTIVE_NOT_RECRUITING
Palo Alto
Florida
AdventHealth Orlando
ACTIVE_NOT_RECRUITING
Orlando
Georgia
Piedmont Heart Institute
ACTIVE_NOT_RECRUITING
Athens
Piedmont Heart Institute
ACTIVE_NOT_RECRUITING
Atlanta
Indiana
Ascension St. Vincent Heart Center
ACTIVE_NOT_RECRUITING
Carmel
Michigan
University of Michigan
ACTIVE_NOT_RECRUITING
Ann Arbor
Minnesota
Mayo Clinic, Rochester
ACTIVE_NOT_RECRUITING
Rochester
Missouri
Washington University Barnes-Jewish Hospital
ACTIVE_NOT_RECRUITING
Saint Louis
North Carolina
Duke University Medical Center
ACTIVE_NOT_RECRUITING
Durham
New York
Columbia University Irving Medical Center
ACTIVE_NOT_RECRUITING
New York
Mount Sinai Hospital
ACTIVE_NOT_RECRUITING
New York
Weill Cornell Medicine
ACTIVE_NOT_RECRUITING
New York
Pennsylvania
Hospital of the University of Pennsylvania
ACTIVE_NOT_RECRUITING
Philadelphia
Allegheny General Hospital
ACTIVE_NOT_RECRUITING
Pittsburgh
UPMC Presbyterian Shadyside
ACTIVE_NOT_RECRUITING
Pittsburgh
Tennessee
Ascension Saint Thomas
ACTIVE_NOT_RECRUITING
Nashville
Tristar Centennial Medical Center
ACTIVE_NOT_RECRUITING
Nashville
Utah
University of Utah
ACTIVE_NOT_RECRUITING
Salt Lake City
Wisconsin
Mayo Clinic Health System - Eau Claire
WITHDRAWN
Eau Claire
Aurora St. Luke's Medical Center
ACTIVE_NOT_RECRUITING
Milwaukee
Other Locations
Canada
London Health Sciences Centre, University Hospital (LHSC)
ACTIVE_NOT_RECRUITING
London
Montreal Heart Institute
ACTIVE_NOT_RECRUITING
Montréal
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
ACTIVE_NOT_RECRUITING
Québec
St. Paul's Hospital and Vancouver General Hospital
ACTIVE_NOT_RECRUITING
Vancouver
Germany
Universitätsklinikum Augsburg
RECRUITING
Augsburg
Herz- und Diabeteszentrum NRW
RECRUITING
Bad Oeynhausen
University Clinic Bonn
RECRUITING
Bonn
Deutsches Herzzentrum München
RECRUITING
München
Contact Information
Primary
Kelly Hendrickson
Kelly_Hendrickson@edwards.com
949-250-2500
Backup
Sabrina Hundt, PhD
Sabrina_Hundt@edwards.com
+49 (0)151 67550601
Time Frame
Start Date: 2023-01-11
Estimated Completion Date: 2035-12
Participants
Target number of participants: 500
Treatments
Patients requiring replacement of their native or prosthetic mitral valve
Patients requiring replacement of their native or prosthetic mitral valve
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences