Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-18 @ 11:33 PM
Study NCT ID:
NCT02210351
Status:
UNKNOWN
Last Update Posted:
2014-08-06
First Post:
2014-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2014-08-05', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in left ventricle ejection fraction', 'timeFrame': 'two months after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Symptomatic Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography.\n2. Symptomatic patients with aortic stenosis referred for medically indicated AVR\n3. Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Inability to sign written informed consent.\n2. Abnormal Apical dysfunction at baseline\n3. LVEF \\< 20%\n4. Pregnancy or breast feeding.\n5. Need for emergency surgery for any reason.\n6. Any case in which the practicing physician asserts that enrollment in the protocol will'}, 'identificationModule': {'nctId': 'NCT02210351', 'briefTitle': 'Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).', 'orgStudyIdInfo': {'id': 'SHEBA-13-0829-DS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI test', 'interventionNames': ['Device: MRI test']}], 'interventions': [{'name': 'MRI test', 'type': 'DEVICE', 'armGroupLabels': ['MRI test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5265601', 'city': 'Ramat Gan', 'country': 'Israel', 'contacts': [{'name': 'Danny Spiegelstein, Dr', 'role': 'CONTACT', 'email': 'Danny.Spiegelstein@sheba.health.gov.il', 'phone': '972-35307339'}], 'facility': 'Leviev Heart Center, Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Danny Spiegelstein, Dr', 'role': 'CONTACT', 'email': 'Danny.Spiegelstein@sheba.health.gov.il', 'phone': '972-35307339'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Danny Spiegelstein, Physician', 'investigatorFullName': 'Dr. Danny Spiegelstein', 'investigatorAffiliation': 'Sheba Medical Center'}}}}