Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-01-11 @ 8:13 PM
Study NCT ID:
NCT06722066
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium 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': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2034-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Echo parameters', 'timeFrame': 'annual follow-up until 3 years'}], 'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '3 years follow-up'}], 'secondaryOutcomes': [{'measure': 'Hospitalization for heart failure', 'timeFrame': '3 years follow-up'}, {'measure': 'Stroke', 'timeFrame': '3 years follow-up'}, {'measure': 'Myocardial infarction', 'timeFrame': '3 years follow-up'}, {'measure': 'Permanent pacemaker insertion', 'timeFrame': '3 years follow-up'}, {'measure': 'Vascular complication', 'timeFrame': '30 days follow-up'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR). The main question it aims to answer is:\n\nDoes the degree of aortic valve annular calcification prior to TAVR influence long-term clinical outcomes, including major adverse cardiovascular events including all-cause mortality, over a 3-year period?\n\nParticipants who have undergone TAVR as part of their regular medical care for severe aortic stenosis will have their pre-procedural imaging and clinical outcomes evaluated for a 3-year follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 19 years or older who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis and have voluntarily expressed their willingness to participate through written informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 19 years or older.\n2. Patients who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis.\n3. Individuals who have voluntarily provided written informed consent to participate.\n\nExclusion Criteria:\n\n1\\. Individuals who have not provided written informed consent for this study.'}, 'identificationModule': {'nctId': 'NCT06722066', 'acronym': 'SAINT-TAVR Ca', 'briefTitle': 'Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry', 'organization': {'class': 'OTHER', 'fullName': "Eunpyeong St. Mary's Hospital"}, 'officialTitle': 'Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: Scientific Association of Interventional Cardiology - Transcatheter Aortic Valve Replacement (SAINT-TAVR) Calcium Registry', 'orgStudyIdInfo': {'id': 'PC24OISI0131'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves', 'type': 'DEVICE', 'description': 'Device: Edwards SAPIEN 3 valve, Medtronic Evolut valve, Boston Acurate Neo valve, or Abbott Navitor Access route: transfemorak, subclavian, transapical, transcarotid, or transcaval The use of balloon dilation will be left to the discretion of the operator.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '122-200', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hye-Yeon Seo, A Master´s degree', 'role': 'CONTACT', 'email': 'hymargie@hanmail.net', 'phone': '+82-10-9151-9028'}], 'facility': "Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Osung Kwon, MD. PhD', 'role': 'CONTACT', 'email': 'oscaesar@gmail.com', 'phone': '+82-10-3708-5673'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Eunpyeong St. Mary's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Osung Kwon', 'investigatorAffiliation': "Eunpyeong St. Mary's Hospital"}}}}