Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
Study NCT ID:
NCT06743568
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000094625', 'term': 'Aneurysm, Ascending Aorta'}], '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': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001018', 'term': 'Aortic 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The present study is a multi-center, open-label, two-arm randomized control trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device success', 'timeFrame': 'Perioperative period', 'description': '(1) freedom from mortality; (2) successful access, delivery of the device, and retrieval of the delivery system; (3) correct positioning of a single prosthetic heart valve into the proper anatomical location; (4) freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; (5) intended performance of the valve (mean gradient \\<20mmHg, peak velocity \\<3m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).'}, {'measure': '30-day all-cause mortality', 'timeFrame': '30 days', 'description': '30-day all-cause mortality'}, {'measure': '30-day adverse aortic events', 'timeFrame': '30 days', 'description': 'Aortic-related death, aortic dissection, or aortic rupture.'}], 'secondaryOutcomes': [{'measure': '1-year all-cause mortality', 'timeFrame': '1 year', 'description': '1-year all-cause mortality'}, {'measure': '1-year cardiovascular mortality', 'timeFrame': '1 year', 'description': '1-year cardiovascular mortality'}, {'measure': '1-year adverse aortic events', 'timeFrame': '1 year', 'description': 'Aortic-related death, aortic dissection, or aortic rupture.'}, {'measure': 'Aortic expansion rate≥3mm/year', 'timeFrame': '1 year', 'description': 'The aortic expansion rate was defined by the change of AA diameter (before the procedure and at the latest follow-up) divided by the follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter aortic valve replacement', 'Balloon-expandable valve', 'Self-expandable valve', 'Aortic stenosis', 'Ascending aortic dilation'], 'conditions': ['Aortic Stenosis', 'Ascending Aortic Dilatation']}, 'descriptionModule': {'briefSummary': 'This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.', 'detailedDescription': 'Ascending aortic dilation (AAD) is a common feature in patients with aortic stenosis, especially in those with bicuspid aortic valve. According to the 2022 AHA/ACC Guideline for the Diagnosis and Management of Aortic Disease, in patients undergoing surgical aortic valve replacement who have a concomitant AAD with a maximum diameter of ≥45mm, ascending aortic replacement is reasonable when performed by experienced surgeons in a Multidisciplinary Aortic Team (Class 2a, Level B-NR). However, in patients undergoing transcatheter aortic valve replacement, the impact of ascending aortic dilation remains unclear. Therefore, we designed this multicenter prospective randomized controlled trial, aiming to assess the efficacy of self-expandable and balloon-expandable valves in patients with AAD with a maximum diameter of ≥45mm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe AS defined as an aortic valve area (AVA) of 1cm2 or less or an indexed AVA of 0.6 cm2/m2 or less;\n* Evaluation and selection for TAVR by the multidisciplinary heart team;\n* Maximum ascending aortic diameter between 45mm and 54mm on preoperative contrast-enhanced computed tomography (CT) scan\n* Anatomic suitability for a transfemoral vascular access;\n* Life expectancy of more than 12 months;\n* Age ≥65 years.\n\nExclusion Criteria:\n\n* Pure aortic regurgitation;\n* History of surgical or transcatheter aortic valve replacement (valve in valve);\n* History of any aortic surgery;\n* Emergent surgery;\n* Patients who refused to be randomized or unable to complete regular follow-up.'}, 'identificationModule': {'nctId': 'NCT06743568', 'briefTitle': 'Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation', 'orgStudyIdInfo': {'id': '2024-2486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Self-expandable valve group', 'description': 'Patients who undergo transcatheter aortic valve replacement using self-expandable valves', 'interventionNames': ['Device: Transcatheter aortic valve replacement']}, {'type': 'OTHER', 'label': 'Balloon-expandable valve group', 'description': 'Patients who undergo transcatheter aortic valve replacement using balloon-expandable valves', 'interventionNames': ['Device: Transcatheter aortic valve replacement']}], 'interventions': [{'name': 'Transcatheter aortic valve replacement', 'type': 'DEVICE', 'description': 'Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.', 'armGroupLabels': ['Balloon-expandable valve group', 'Self-expandable valve group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kang An, MD', 'role': 'CONTACT', 'email': 'ankang913@126.com', 'phone': '+86-15801301740'}], 'facility': 'National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiguo Li, MD', 'role': 'CONTACT', 'email': 'drneal@163.com', 'phone': '+86-15801178630'}], 'facility': 'Fuwai Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Kunming', 'state': 'Yunnan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenbin Ouyang, MD', 'role': 'CONTACT', 'email': 'victorzhu909@163.com', 'phone': '+86-15601827502'}], 'facility': 'Fuwai Yunnan Cardiovascular Hospital', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Kang An, MD', 'role': 'CONTACT', 'email': 'ankang913@126.com', 'phone': '+86-15801301740'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}