Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-04-21 @ 8:39 PM
Study NCT ID:
NCT03051334
Status:
UNKNOWN
Last Update Posted:
2017-02-13
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ascending Aortic Dilation in BiAV After TAVR
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in dimension of ascending aorta', 'timeFrame': 'baseline and 1year after TAVR', 'description': 'the annual growth rate of ascending aorta(mm/year) using echocardiography'}]}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).', 'detailedDescription': 'The growth rate of ascending aorta was calculated as annual growth rate using baseline and the last echocardiography. The difference in ascending aorta growth rates between the two groups (BiAV and TAV) were analyzed by independent t-test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severe AS who underwent TAVR', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe AS who underwent TAVR\n\nExclusion Criteria:\n\n* ascending aorta more than 50mm'}, 'identificationModule': {'nctId': 'NCT03051334', 'briefTitle': 'Ascending Aortic Dilation in BiAV After TAVR', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Changes in Ascending Aorta Size After Transcatheter Aortic Valve Replacement in Severe Bicuspid Aortic Stenosis: A Pilot Study With Echocardiographic Follow-up', 'orgStudyIdInfo': {'id': '1701-104-825'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BiAV', 'description': 'Bicuspid aortic valve', 'interventionNames': ['Other: diagnosed as bicuspid aortic valve']}, {'label': 'TAV', 'description': 'Tricuspid aortic valve'}], 'interventions': [{'name': 'diagnosed as bicuspid aortic valve', 'type': 'OTHER', 'armGroupLabels': ['BiAV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyung-Kwan Kim, MD', 'role': 'CONTACT', 'phone': '82-2-2072-0243'}, {'name': 'Hyung-Kwan Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ji-Hyun Jung, MD', 'role': 'CONTACT', 'email': 'jbjhyun@naver.com', 'phone': '82-2-2072-0243'}, {'name': 'Hyung-Kwan Kim, MD, PhD', 'role': 'CONTACT', 'phone': '82-2-2072-0243'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Division of Cardiology, Clinical Professor', 'investigatorFullName': 'Hyung-Kwan Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}