Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-03-09 @ 1:29 AM
Study NCT ID:
NCT02523066
Status:
TERMINATED
Last Update Posted:
2025-05-18
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Echocardiography to evaluate the performance of heart valve', 'timeFrame': 'Up to five years after surgery', 'description': 'Subjects are required to do eight times echocardiography in follow up visits'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mitral Valve or Aortic Valve Replacement']}, 'descriptionModule': {'briefSummary': 'Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who had the heart valves (Type: 7300TFX and 3300TFX), and are willing to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients who implanted with Magna Ease Heart Valve (Type:7300TFX and 3300TFX) in Fuwai Hospital in China.\n* The patients agree to sign the inform consent form (ICF).\n\nExclusion Criteria:\n\n* No specific exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT02523066', 'briefTitle': 'Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients', 'orgStudyIdInfo': {'id': 'Magna Ease CN001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mitral Valve or Aortic Valve Replancement', 'description': 'One-arm group', 'interventionNames': ['Device: Magna Ease']}], 'interventions': [{'name': 'Magna Ease', 'type': 'DEVICE', 'description': 'This study is non-intervention', 'armGroupLabels': ['Mitral Valve or Aortic Valve Replancement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The Chinese academy of medical sciences fuwai hospital cardiovascular disease', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}