Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-04-17 @ 4:21 PM
Study NCT ID:
NCT05526560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-29
First Post:
2022-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008946', 'term': 'Mitral Valve Stenosis'}, {'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008954', 'term': 'Models, Biological'}], 'ancestors': [{'id': 'D008962', 'term': 'Models, Theoretical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from valve related death or valve related reintervention', 'timeFrame': '1 year', 'description': 'Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee'}, {'measure': 'Hemodynamic performance as measured by peak and mean gradient by echocardiography', 'timeFrame': '1 year', 'description': 'Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation'}], 'secondaryOutcomes': [{'measure': 'Early rates of major cardiac events', 'timeFrame': '0 to 30 days', 'description': 'Early (\\<=30 days) rates of major cardiac events'}, {'measure': 'Late linearized rates of major cardiac events', 'timeFrame': '>30 days and up through 10 years post implant', 'description': 'Linearized rates of late (\\>30 days) major cardiac events'}, {'measure': 'Functional improvement from baseline for New York Heart Association (NYHA) Class', 'timeFrame': 'Annually up to 10 years post implant', 'description': 'Functional improvement from baseline for NYHA Class'}, {'measure': 'Improvement from baseline for Quality of Life', 'timeFrame': '1, 3, 5, 8, and 10 years post implant', 'description': '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)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Mitral Valve Replacement'], 'conditions': ['Mitral Stenosis', 'Mitral Valve Insufficiency']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring replacement of their native or prosthetic mitral valve', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older at the time of informed consent\n* Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery\n* Provides written informed consent\n* Willingness to follow protocol requirements\n\nExclusion Criteria:\n\n* Active endocarditis 3 months prior to the procedure\n* Stage 4 renal disease or requiring dialysis\n* Less than 2-year life expectancy due to non-cardiovascular life-threatening disease\n* High predicted risk of mortality prior to procedure\n\n * Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of \\> 8 or\n * Surgeon estimated risk of mortality of \\> 8'}, 'identificationModule': {'nctId': 'NCT05526560', 'acronym': 'MOMENTIS', 'briefTitle': 'Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve', 'orgStudyIdInfo': {'id': '2022-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients requiring replacement of their native or prosthetic mitral valve', 'description': 'Patients requiring replacement of their native or prosthetic mitral valve', 'interventionNames': ['Device: MITRIS RESILIA Mitral Valve, Model 11400M']}], 'interventions': [{'name': 'MITRIS RESILIA Mitral Valve, Model 11400M', 'type': 'DEVICE', 'description': 'Replacement of mitral valve with MITRIS RESLIA Mitral Valve', 'armGroupLabels': ['Patients requiring replacement of their native or prosthetic mitral valve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30606', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46290', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Ascension St. Vincent Heart Center', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic, Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian Shadyside', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tristar Centennial Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Ascension Saint Thomas', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital and Vancouver General Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'N6G 5G1', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre, University Hospital (LHSC)', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'QC G1V 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': 'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '97616', 'city': 'Bad Neustadt an der Saale', 'country': 'Germany', 'facility': 'Rhoen-Klinikum Campus Bad Neustadt', 'geoPoint': {'lat': 50.32174, 'lon': 10.20673}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'University Clinic Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '28277', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum Links der Weser', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '80636', 'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': 'SE5 9RS', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Royal Papworth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St. Thomas Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW1X 7HY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Cleveland Clinic London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Gorav Ailawadi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}