Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT02023060
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2030-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2013-12-22', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcome of patients undergoing transcatheter valve replacement', 'timeFrame': '12 months', 'description': 'Mortality, change in New York Heart Association class, change in ejection fraction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Trans Catheter Aortic Valve', 'Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '32022390', 'type': 'DERIVED', 'citation': 'Zusman O, Barbash MI, Guetta V, Finkelstein A, Assali A, Segev A, Orvin K, Barsheshet A, Younis A, Witberg G, Kornowski R, Danenberg H, Landes U. Predicting the risk of late futile outcome after transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2020 Dec;96(7):E695-E702. doi: 10.1002/ccd.28761. Epub 2020 Feb 5.'}, {'pmid': '30636515', 'type': 'DERIVED', 'citation': 'Brodov Y, Konen E, Di Segni M, Samoocha D, Chernomordik F, Barbash I, Regev E, Raanani E, Guetta V, Segev A, Fefer P, Glikson M, Goitein O. Mitral Annulus Calcium Score. Circ Cardiovasc Imaging. 2019 Dec;12(1):e007508. doi: 10.1161/CIRCIMAGING.117.007508.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.', 'detailedDescription': 'To observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with severe aortic or mitral valve dysfunction (stenosis or regurgitation) selected for transcatheter aortic or mitral valve replacement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject selected for transcatheter heart valve replacement\n2. Signed informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Inability to sign written informed consent.\n2. Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).'}, 'identificationModule': {'nctId': 'NCT02023060', 'briefTitle': 'Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation', 'orgStudyIdInfo': {'id': 'SHEBA-13-0685-IB-CTIL'}}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gideon Perlman', 'role': 'CONTACT'}], 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Elad Asher', 'role': 'CONTACT'}], 'facility': 'Shaarei Zedek amedical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Alon Barsheshet', 'role': 'CONTACT'}], 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arik Steinvil', 'role': 'CONTACT'}], 'facility': 'Tel Aviv Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Israel Barbash, MD', 'role': 'CONTACT', 'phone': '+97235305273'}], 'overallOfficials': [{'name': 'Israel Barbash, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sheba Medical Center, Tel Hashomer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}