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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.
MOMENTIS is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients requiring replacement of their native or prosthetic mitral valve | Patients requiring replacement of their native or prosthetic mitral valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MITRIS RESILIA Mitral Valve, Model 11400M | Device | Replacement of mitral valve with MITRIS RESLIA Mitral Valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from valve related death or valve related reintervention | Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee | 1 year |
| Hemodynamic performance as measured by peak and mean gradient by echocardiography | Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Early rates of major cardiac events | Early (<=30 days) rates of major cardiac events | 0 to 30 days |
| Late linearized rates of major cardiac events | Linearized rates of late (>30 days) major cardiac events |
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Inclusion Criteria:
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
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Patients requiring replacement of their native or prosthetic mitral valve
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| Name | Affiliation | Role |
|---|---|---|
| Gorav Ailawadi, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | United States | ||
| Stanford University |
Individual participant data will not be available to other researchers.
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| >30 days and up through 10 years post implant |
| Functional improvement from baseline for New York Heart Association (NYHA) Class | Functional improvement from baseline for NYHA Class | Annually up to 10 years post implant |
| Improvement from baseline for Quality of Life | Improvement from baseline for Quality of Life as measured by the Short Form (36) Health Survey (SF-36v2) (0-100 scale, with a higher score indicating less disability) | 1, 3, 5, 8, and 10 years post implant |
| Palo Alto |
| California |
| 94305 |
| United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Piedmont Heart Institute | Athens | Georgia | 30606 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Ascension St. Vincent Heart Center | Carmel | Indiana | 46290 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27703 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UPMC Presbyterian Shadyside | Pittsburgh | Pennsylvania | 15232 | United States |
| Tristar Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Ascension Saint Thomas | Nashville | Tennessee | 37205 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| St. Paul's Hospital and Vancouver General Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| London Health Sciences Centre, University Hospital (LHSC) | London | Ontario | N6G 5G1 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval | Québec | QC G1V 4G5 | Canada |
| Universitätsklinikum Augsburg | Augsburg | 86156 | Germany |
| Rhoen-Klinikum Campus Bad Neustadt | Bad Neustadt an der Saale | 97616 | Germany |
| Herz- und Diabeteszentrum NRW | Bad Oeynhausen | 32545 | Germany |
| University Clinic Bonn | Bonn | 53127 | Germany |
| Klinikum Links der Weser | Bremen | 28277 | Germany |
| Deutsches Herzzentrum München | München | 80636 | Germany |
| Royal Papworth Hospital | Cambridge | SE5 9RS | United Kingdom |
| St. Thomas Hospital | London | SE1 7EH | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Cleveland Clinic London | London | SW1X 7HY | United Kingdom |
| ID | Term |
|---|---|
| D008946 | Mitral Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008954 | Models, Biological |
| ID | Term |
|---|---|
| D008962 | Models, Theoretical |
| D008919 | Investigative Techniques |
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