Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-12 @ 6:22 AM
Study NCT ID:
NCT02308150
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2014-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Asian Transcatheter Aortic Valve Replacement Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D001018', 'term': 'Aortic Diseases'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1505}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '1 month'}, {'measure': 'Death', 'timeFrame': '6 months'}, {'measure': 'Death', 'timeFrame': '1 year'}, {'measure': 'Death', 'timeFrame': '2 years'}, {'measure': 'Death', 'timeFrame': '3 years'}, {'measure': 'Death', 'timeFrame': '4 years'}, {'measure': 'Death', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Death from cardiac cause', 'timeFrame': '1 month'}, {'measure': 'Death from cardiac cause', 'timeFrame': '6 months'}, {'measure': 'Death from cardiac cause', 'timeFrame': '1 year'}, {'measure': 'Death from cardiac cause', 'timeFrame': '2 years'}, {'measure': 'Death from cardiac cause', 'timeFrame': '3 years'}, {'measure': 'Death from cardiac cause', 'timeFrame': '4 years'}, {'measure': 'Death from cardiac cause', 'timeFrame': '5 years'}, {'measure': 'Stroke', 'timeFrame': '1 month'}, {'measure': 'Stroke', 'timeFrame': '6 months'}, {'measure': 'Stroke', 'timeFrame': '1 year'}, {'measure': 'Stroke', 'timeFrame': '2 years'}, {'measure': 'Stroke', 'timeFrame': '3 years'}, {'measure': 'Stroke', 'timeFrame': '4 years'}, {'measure': 'Stroke', 'timeFrame': '5 years'}, {'measure': 'Myocardial infarction', 'timeFrame': '1 month'}, {'measure': 'Myocardial infarction', 'timeFrame': '6 months'}, {'measure': 'Myocardial infarction', 'timeFrame': '1 year'}, {'measure': 'Myocardial infarction', 'timeFrame': '2 years'}, {'measure': 'Myocardial infarction', 'timeFrame': '3 years'}, {'measure': 'Myocardial infarction', 'timeFrame': '4 years'}, {'measure': 'Myocardial infarction', 'timeFrame': '5 years'}, {'measure': 'Repeat hospitalization', 'timeFrame': '1 month'}, {'measure': 'Repeat hospitalization', 'timeFrame': '6 months'}, {'measure': 'Repeat hospitalization', 'timeFrame': '1 year'}, {'measure': 'Repeat hospitalization', 'timeFrame': '2 years'}, {'measure': 'Repeat hospitalization', 'timeFrame': '3 years'}, {'measure': 'Repeat hospitalization', 'timeFrame': '4 years'}, {'measure': 'Repeat hospitalization', 'timeFrame': '5 years'}, {'measure': 'Acute kidney injury', 'timeFrame': '1 month'}, {'measure': 'Acute kidney injury', 'timeFrame': '6 months'}, {'measure': 'Acute kidney injury', 'timeFrame': '1 year'}, {'measure': 'Acute kidney injury', 'timeFrame': '2 years'}, {'measure': 'Acute kidney injury', 'timeFrame': '3 years'}, {'measure': 'Acute kidney injury', 'timeFrame': '4 years'}, {'measure': 'Acute kidney injury', 'timeFrame': '5 years'}, {'measure': 'Vascular complication', 'timeFrame': '1 month'}, {'measure': 'Vascular complication', 'timeFrame': '6 months'}, {'measure': 'Vascular complication', 'timeFrame': '1 year'}, {'measure': 'Vascular complication', 'timeFrame': '2 years'}, {'measure': 'Vascular complication', 'timeFrame': '3 years'}, {'measure': 'Vascular complication', 'timeFrame': '4 years'}, {'measure': 'Vascular complication', 'timeFrame': '5 years'}, {'measure': 'Bleeding events', 'timeFrame': '1 month'}, {'measure': 'Bleeding events', 'timeFrame': '6 months'}, {'measure': 'Bleeding events', 'timeFrame': '1 year'}, {'measure': 'Bleeding events', 'timeFrame': '2 years'}, {'measure': 'Bleeding events', 'timeFrame': '3 years'}, {'measure': 'Bleeding events', 'timeFrame': '4 years'}, {'measure': 'Bleeding events', 'timeFrame': '5 years'}, {'measure': 'Device success', 'timeFrame': '1 month'}, {'measure': 'Device success', 'timeFrame': '6 months'}, {'measure': 'Device success', 'timeFrame': '1 year'}, {'measure': 'Device success', 'timeFrame': '2 years'}, {'measure': 'Device success', 'timeFrame': '3 years'}, {'measure': 'Device success', 'timeFrame': '4 years'}, {'measure': 'Device success', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transcatheter aortic valve replacement', 'asian pacific', 'asian'], 'conditions': ['Aortic Valve Stenosis', 'Aortic Diseases']}, 'referencesModule': {'references': [{'pmid': '27151607', 'type': 'DERIVED', 'citation': 'Yoon SH, Ahn JM, Hayashida K, Watanabe Y, Shirai S, Kao HL, Yin WH, Lee MK, Tay E, Araki M, Yamanaka F, Arai T, Lin MS, Park JB, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Muramatsu T, Hanyu M, Kozuma K, Kim HS, Saito S, Park SJ; Asian TAVR Investigators. Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population. JACC Cardiovasc Interv. 2016 May 9;9(9):926-33. doi: 10.1016/j.jcin.2016.01.047.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in the Asian Pacific population', 'detailedDescription': 'This registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who will undergo TAVR in Asian Pacific countries', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses\n* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site'}, 'identificationModule': {'nctId': 'NCT02308150', 'acronym': 'Asian TAVR', 'briefTitle': 'The Asian Transcatheter Aortic Valve Replacement Registry', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Pacific Population', 'orgStudyIdInfo': {'id': 'AMCCV2014-14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transcatheter aortic valve replacement', 'type': 'DEVICE', 'otherNames': ['TAVR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Kamakura', 'country': 'Japan', 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'city': 'Kitakyushu', 'country': 'Japan', 'facility': 'Kokura Memorial Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Minato', 'country': 'Japan', 'facility': 'Keio University', 'geoPoint': {'lat': 34.2152, 'lon': 135.1501}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Teikyo University School of medicine', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Saiseikai Yokohama-city Eastern Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Heart Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '138-736', 'city': 'Seoul', 'state': 'Songpa-gu', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Sejong Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Seung-jung Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Paul Hsien Li Kao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}, {'name': 'Shigeru Saito, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shonan Kamakura General Hospital, Japan'}, {'name': 'Gerald Yong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Perth Hospital, Australia'}, {'name': 'Kentaro Hayashida, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keio University, JAPAN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is not a publicly funded trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}