Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04073420
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2019-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medtronic Cardiac Surgery PMCF Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2700}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2039-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-08-28', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify unique failure modes', 'timeFrame': '10 years'}, {'measure': 'Identify trends in adverse device effects', 'timeFrame': '10 years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Valve Disease, Heart']}, 'descriptionModule': {'briefSummary': 'This registry is being conducted to support ongoing post-market surveillance activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects requiring heart valve therapy replacement and/or repair.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements\n2. Patient has or is intended to receive or be treated with an eligible product\n3. Patient is within enrollment window of treatment/therapy received at the time of their initial Registry enrollment, or meets criteria for retrospective enrollment\n\nExclusion Criteria:\n\n1. Patient who is, or is expected to be, inaccessible for follow-up\n2. Patient prohibited from participation by local law\n3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or device study that may confound results'}, 'identificationModule': {'nctId': 'NCT04073420', 'briefTitle': 'Medtronic Cardiac Surgery PMCF Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Surgery'}, 'officialTitle': 'Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry', 'orgStudyIdInfo': {'id': 'MDT18061SUR003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical Valve Replacement and/or Repair Patients', 'interventionNames': ['Device: Surgical Heart Valve Repair Products', 'Device: Surgical Heart Valve Replacement Products']}], 'interventions': [{'name': 'Surgical Heart Valve Repair Products', 'type': 'DEVICE', 'description': 'Surgical heart valve repair products.', 'armGroupLabels': ['Surgical Valve Replacement and/or Repair Patients']}, {'name': 'Surgical Heart Valve Replacement Products', 'type': 'DEVICE', 'description': 'Surgical heart valve replacement products.', 'armGroupLabels': ['Surgical Valve Replacement and/or Repair Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Richard Myung, MD', 'role': 'CONTACT'}], 'facility': 'WellStar Kennestone Hospital', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bolling Steven, MD', 'role': 'CONTACT'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ahmed El-Eshmawi, MD', 'role': 'CONTACT'}], 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Saint Francis Hospital', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'zip': '13203', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karikehalli Dilip, MD', 'role': 'CONTACT'}], 'facility': 'Saint Josephs Hospital Health Center', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brittany Zwishchenberger, MD', 'role': 'CONTACT'}], 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yasir Abu-Omar, MD', 'role': 'CONTACT'}], 'facility': 'University Hospitals Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Johannes Bonatti, MD', 'role': 'CONTACT'}], 'facility': 'University of Pittsburgh Medical Center UPMC Presbyterian', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenneth Liao, MD', 'role': 'CONTACT'}], 'facility': "Baylor St. Luke's Medical Center", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Timothy George, MD', 'role': 'CONTACT'}], 'facility': 'The Heart Hospital Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Sarin, MD', 'role': 'CONTACT'}], 'facility': 'Inova', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Martin Andreas, Prof', 'role': 'CONTACT'}], 'facility': 'Allgemeines Krankenhaus - Universitätskliniken Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Tom Verbelen, MD', 'role': 'CONTACT'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '33604', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Louis Labrousse, Prof', 'role': 'CONTACT'}], 'facility': 'Hôpital Haut-Lévêque - CHU de Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '49214', 'city': 'Bad Rothenfelde', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nicolas Doll, Prof', 'role': 'CONTACT'}], 'facility': 'Schüchtermann-Klinik', 'geoPoint': {'lat': 52.11667, 'lon': 8.16667}}, {'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Klaus Matschke, MD', 'role': 'CONTACT'}], 'facility': 'Herzzentrum Dresden GmbH Universitätsklinik', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christina Ballazs, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '22457', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Friedrich-Christian Rieβ, Prof', 'role': 'CONTACT'}], 'facility': 'Albertinen-Herz- und Gefäßzentrum', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Borger, MD', 'role': 'CONTACT'}], 'facility': 'Herzzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '80636', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Keti Vitanova, MD', 'role': 'CONTACT'}], 'facility': 'Deutsches Herzzentrum München Klinik an der TU München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '17674', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'George Stavridis, MD', 'role': 'CONTACT'}], 'facility': 'Onassis Cardiac Surgery Center', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '54100', 'city': 'Massa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Solinas, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Pasquinucci Massa', 'geoPoint': {'lat': 44.03541, 'lon': 10.13927}}, {'city': 'San Donato', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Dr. Andrea Daprati', 'role': 'CONTACT'}], 'facility': 'IRCCS Policlinico', 'geoPoint': {'lat': 45.08201, 'lon': 7.66485}}, {'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jerry Braun, MD', 'role': 'CONTACT'}], 'facility': 'Leids Universitair Medisch Centrum', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Enrique Ruiz Alonso, Dr.', 'role': 'CONTACT'}], 'facility': 'Hospital Regional Universitario Carlos Haya Málaga - Hospital General', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Matthias Siepe, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Inselspital - Universitätsspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Lisa Slusser', 'role': 'CONTACT', 'email': 'rs.hvtpmcfregistry@medtronic.com', 'phone': '1-800-328-2518'}, {'name': 'Jessica Halverson', 'role': 'CONTACT', 'email': 'rs.hvtpmcfregistry@medtronic.com', 'phone': '1-800-328-2518'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Surgery', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}