Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02195102
Status:
UNKNOWN
Last Update Posted:
2014-11-18
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Asian Pacific TAVR Multicenter Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], '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'}]}, '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': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-07-17', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death from any cause', 'timeFrame': '1 month'}, {'measure': 'Death from any cause', 'timeFrame': '6 months'}, {'measure': 'Death from any cause', 'timeFrame': '1 year'}, {'measure': 'Death from any cause', 'timeFrame': '2 years'}, {'measure': 'Death from any cause', 'timeFrame': '3 years'}, {'measure': 'Death from any cause', 'timeFrame': '4 years'}, {'measure': 'Death from any cause', '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', 'description': 'Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \\<20 mmHg or peak velocity \\< 3 m/s, and no moderate or severe paravalvular regurgitation)'}, {'measure': 'Device success', 'timeFrame': '6 months', 'description': 'Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \\<20 mmHg or peak velocity \\< 3 m/s, and no moderate or severe paravalvular regurgitation)'}, {'measure': 'Device success', 'timeFrame': '1 year', 'description': 'Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \\<20 mmHg or peak velocity \\< 3 m/s, and no moderate or severe paravalvular regurgitation)'}, {'measure': 'Device success', 'timeFrame': '2 years', 'description': 'Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \\<20 mmHg or peak velocity \\< 3 m/s, and no moderate or severe paravalvular regurgitation)'}, {'measure': 'Device success', 'timeFrame': '3 years', 'description': 'Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \\<20 mmHg or peak velocity \\< 3 m/s, and no moderate or severe paravalvular regurgitation)'}, {'measure': 'Device success', 'timeFrame': '4 years', 'description': 'Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \\<20 mmHg or peak velocity \\< 3 m/s, and no moderate or severe paravalvular regurgitation)'}, {'measure': 'Device success', 'timeFrame': '5 years', 'description': 'Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \\<20 mmHg or peak velocity \\< 3 m/s, and no moderate or severe paravalvular regurgitation)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transcatheter aortic valve Replacement'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who had undergone transcatheter aortic valve replacement on the basis of inclusion criteria were prospectively\\&retrospectively included in the registry', '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': 'NCT02195102', 'acronym': 'AP TAVR', 'briefTitle': 'The Asian Pacific TAVR Multicenter Registry', 'organization': {'class': 'OTHER', 'fullName': 'Queen Elizabeth Hospital, Hong Kong'}, 'officialTitle': 'Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY', 'orgStudyIdInfo': {'id': 'AMCCV 2013-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'transcatheter aortic valve Replacement', 'description': 'Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.', 'interventionNames': ['Device: Transcatheter aortic valve Replacement']}], 'interventions': [{'name': 'Transcatheter aortic valve Replacement', 'type': 'DEVICE', 'armGroupLabels': ['transcatheter aortic valve Replacement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'contacts': [{'name': 'Michael Kang-Yin Lee, MD', 'role': 'CONTACT', 'email': 'kylee1991@hotmail.com'}, {'name': 'Michael Kang-Yin Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Nanjing', 'country': 'China', 'contacts': [{'name': 'Jun-Jie Zhang, MD', 'role': 'CONTACT', 'email': 'jameszll@163.com'}, {'name': 'Jun-Jie Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing 1st Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Kamakura', 'country': 'Japan', 'contacts': [{'name': 'Shigeru Saito, MD', 'role': 'CONTACT', 'email': 'saito@shonankamakura.or.jp'}, {'name': 'Shigeru Saito, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'contacts': [{'name': 'Rosli Mohd Ali, MD', 'role': 'CONTACT', 'email': 'rosli@ijn.com.my'}, {'name': 'Rosli Mohd Ali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Jantung Negara', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Bonifacio', 'country': 'Philippines', 'contacts': [{'name': 'Enrique Fabio Posas, MD', 'role': 'CONTACT', 'email': 'febposas@gmail.com'}, {'name': 'Enrique Fabio Posas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 8.0525, 'lon': 123.6142}}, {'city': 'Singapore', 'country': 'Singapore', 'contacts': [{'name': 'Paul Chiam, MD', 'role': 'CONTACT', 'email': 'paul.chiam.t.l@nhcs.com.sg'}, {'name': 'Paul Chiam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Heart Centre of Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'country': 'Singapore', 'contacts': [{'name': 'Edgar L.W. Tay, MD', 'role': 'CONTACT', 'email': 'Edgar_Tay@nuhs.edu.sg'}, {'name': 'Edgar L.W. Tay, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National University Heart Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Jeong-youn Bae, Research nurse', 'role': 'CONTACT', 'email': 'cvcrc10@amc.seoul.kr'}, {'name': 'Seung-jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Paul Kao, MD', 'role': 'CONTACT', 'email': 'hsienli_kao@yahoo.com'}, {'name': 'Paul Kao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Bangkok', 'country': 'Thailand', 'contacts': [{'name': 'Wacin Buddhari, MD', 'role': 'CONTACT', 'email': 'wacin_buddhari@yahoo.com'}, {'name': 'Wacin Buddhari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Elly Jeong-youn Bae, Research Nurse', 'role': 'CONTACT', 'email': 'cvcrc10@amc.seoul.kr'}], 'overallOfficials': [{'name': 'Seung-jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center, Republic of Korea'}, {'name': 'Edgar L.W. Tay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Heart Center (National University Health System), Singapore'}, {'name': 'Machael Kang-Yin Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Elizabeth Hospital, HongKong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Kang-Yin Lee, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Cardiovascular Clinical Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Michael Kang-Yin Lee, MD', 'investigatorAffiliation': 'Queen Elizabeth Hospital, Hong Kong'}}}}