Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-20 @ 3:55 PM
Study NCT ID:
NCT05977257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-04
First Post:
2023-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2028-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-28', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '7years after the operation', 'description': 'rate of all cause mortality'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '6 years, 7 years, 8 years, 9 years and 10 years after the operation', 'description': 'rate of Cardiac death'}, {'measure': 'Stroke', 'timeFrame': '6 years, 7 years, 8 years, 9 years and 10 years after the operation', 'description': 'rate of stroke'}, {'measure': 'valve-related rehospitalization', 'timeFrame': '6 years, 7 years, 8 years, 9 years and 10 years after the operation', 'description': 'rate of valve-related rehospitalization'}, {'measure': 'Serious Adverse Event', 'timeFrame': '6 years, 7 years, 8 years, 9 years and 10 years after the operation', 'description': 'rate of Serious Adverse Event'}, {'measure': 'Blood pressure', 'timeFrame': '6 years, 7 years, 8 years, 9 years and 10 years after the operation', 'description': 'Systolic and Diastolic Blood Pressure'}, {'measure': 'The 12-Item Short Form Health Survey (SF-12)', 'timeFrame': '6years, 7years, 8 years, 9 years and 10 years after the operation', 'description': 'Scores range from 0 to 100, higher scores are better'}, {'measure': 'Mean transvalvular pressure gradient', 'timeFrame': '7years,and 10 years after the operation', 'description': 'Transthoracic Echocardiogram test'}, {'measure': 'Effective orifice area', 'timeFrame': '7years,and 10 years after the operation', 'description': 'Transthoracic Echocardiogram test'}, {'measure': 'Peak velocity', 'timeFrame': '7years,and 10 years after the operation', 'description': 'Transthoracic Echocardiogram test'}, {'measure': 'class of Paravalvular leak', 'timeFrame': '7years,and 10 years after the operation', 'description': 'Transthoracic Echocardiogram test'}, {'measure': 'class of Aortic regurgitation', 'timeFrame': '7years,and 10 years after the operation', 'description': 'Transthoracic Echocardiogram test'}, {'measure': 'New York Heart Association Class for heart function', 'timeFrame': '7years,and 10 years after the operation', 'description': 'NYHA class'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire', 'timeFrame': '7years,and 10 years after the operation', 'description': 'Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better'}, {'measure': 'Natriuretic peptide tests ( NT Pro-BNP or BNP)', 'timeFrame': '7years,and 10 years after the operation', 'description': 'blood test'}, {'measure': 'moderate and severe structural valve deterioration SVD', 'timeFrame': '7years,and 10 years after the operation', 'description': 'Transthoracic Echocardiogram test'}, {'measure': 'bioprosthetic valve failure，BVF', 'timeFrame': '7years,and 10 years after the operation', 'description': 'Transthoracic Echocardiogram test'}, {'measure': 'All cause mortality', 'timeFrame': '6 years, 8 years, 9 years and 10 years after the operation', 'description': 'rate of all cause mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Disease', 'Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.', 'detailedDescription': 'This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must meet 1, 2, 3, 4 or 1, 5 to be selected:\n\n 1. Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions\\*;\n 2. Be able to get in touch with the patient or his legal guardian/relative;\n 3. Patients who can understand the purpose and nature of the follow-up of this study, and are willing to cooperate with the follow-up and provide follow-up information;\n 4. Sign the informed consent form;\n 5. Patients who are known to have died.\n\n * 4 research institutions: Zhongshan Hospital Fudan University, Second Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University and Fuwai Hospital.\n\nExclusion Criteria:\n\n1. Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint;\n2. The investigator judges that the patient's compliance is poor and the study cannot be completed as required."}, 'identificationModule': {'nctId': 'NCT05977257', 'acronym': 'VITAL', 'briefTitle': 'VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai MicroPort CardioFlow Medtech Co., Ltd.'}, 'officialTitle': 'VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）', 'orgStudyIdInfo': {'id': 'VITAL-2023-192R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non Interventional long term safety follow up', 'description': 'Non Interventional long term safety follow up', 'interventionNames': ['Device: VitaFlow® Transcatheter Aortic Valve Replacement System']}], 'interventions': [{'name': 'VitaFlow® Transcatheter Aortic Valve Replacement System', 'type': 'DEVICE', 'description': 'This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial', 'armGroupLabels': ['Non Interventional long term safety follow up']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Yongjian Wu', 'role': 'CONTACT'}], 'facility': 'Fuwai CVD Hospital of Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chengdu', 'country': 'China', 'contacts': [{'name': 'Yuan Feng', 'role': 'CONTACT'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Hangzhou', 'country': 'China', 'contacts': [{'name': 'Jianan Wang', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Daxin Zhou', 'role': 'CONTACT'}, {'name': 'Daxin Zhou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'JIATONG ZHANG', 'role': 'CONTACT', 'email': 'JiaTong.Zhang@microport.com', 'phone': '+8617797187661'}], 'overallOfficials': [{'name': 'Daxin Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai MicroPort CardioFlow Medtech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}