Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-01 @ 1:23 PM
Study NCT ID:
NCT07058935
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV 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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'From date of procedure to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valve Disease, Heart']}, 'descriptionModule': {'briefSummary': 'A retrospective and prospective, observational, multicenter cohort study of consecutive patients undergoing transcatheter mitral/tricuspid ViV or ViR procedure with balloon expandable valve across participating sites in Asia-Pacific.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing transcatheter mitral/tricuspid ViV or ViR procedure with balloon expandable valve across participating sites in Asia-Pacific from 1 Jan 2023 to 31 Dec 2035.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 21\n2. Had at least one documented Mitral valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Mitral valve-in-valve/valve-in-ring procedure. (Prospective) OR Had at least one documented Tricuspid valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Tricuspid valve-in-valve/valve-in-ring procedure. (Prospective)\n\nExclusion Criteria:\n\n1. Active endocarditis\n2. Any other conditions which investigator deems unsuitable for participation.'}, 'identificationModule': {'nctId': 'NCT07058935', 'briefTitle': 'The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)', 'organization': {'class': 'OTHER', 'fullName': 'National Heart Centre Singapore'}, 'officialTitle': 'The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)', 'orgStudyIdInfo': {'id': '2024-4264'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mitral Valve-in-Valve', 'description': 'Patients who have undergone or will undergo a transcatheter mitral valve-in-valve procedure.'}, {'label': 'Mitral Valve-in-Ring', 'description': 'Patients who have undergone or will undergo a transcatheter mitral valve-in-ring procedure.'}, {'label': 'Tricuspid Valve-in-Valve', 'description': 'Patients who have undergone or will undergo a transcatheter tricuspid valve-in-valve procedure.'}, {'label': 'Tricuspid Valve-in-Ring', 'description': 'Patients who have undergone or will undergo a transcatheter tricuspid valve-in-ring procedure.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Lambton Heights', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'Anne.Gordon@health.nsw.gov.au', 'phone': '02 4985 5433'}, {'name': 'Dr Rohan Bhagwandeen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Hunter Hospital', 'geoPoint': {'lat': -32.92466, 'lon': 151.69364}}, {'city': 'Hong Kong', 'status': 'NOT_YET_RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'danielxu@cuhk.edu.hk', 'phone': '+852-35052211'}, {'name': 'Dr Kent So Chak Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'status': 'NOT_YET_RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'lois.qeh@gmail.com', 'phone': '+852-35061088'}, {'name': 'Dr Angus Chui Shing Fung', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Chennai', 'state': 'Tamil Nadu', 'status': 'NOT_YET_RECRUITING', 'country': 'India', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'secretary@gopalamurugan.com', 'phone': '9677178012'}, {'name': 'Dr AB Gopalamurugan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MGM Healthcare Pvt Ltd', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Chennai', 'state': 'Tamil Nadu', 'status': 'NOT_YET_RECRUITING', 'country': 'India', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'clireco@mmm.org.in', 'phone': '9940484306'}, {'name': 'Dr Ajit Mullasari', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Madras Medical Mission', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Hamilton', 'status': 'NOT_YET_RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'simi.christudasjayakumari@waikatodhb.health.nz', 'phone': '+64 7 839 7136'}, {'name': 'Dr Faeez Mohamad Ali', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'lim.yu.fei@nhcs.com.sg', 'phone': '+65-7042274'}, {'name': 'A/Prof Jonathan Yap', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Heart Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Bangkok', 'status': 'NOT_YET_RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'Pachpan@hotmail.com', 'phone': '+66819068607'}, {'name': 'Dr Mann Chandavimol', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Deborah Yip', 'role': 'CONTACT', 'email': 'deborah.yip.x.y@singhealth.com.sg', 'phone': '+65-67042301'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart Centre Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}