Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 7:14 PM
Study NCT ID:
NCT03474250
Status:
UNKNOWN
Last Update Posted:
2018-05-01
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans-aortic Valve Replacement and Renal Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-28', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-03-15', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New Renal Infarction', 'timeFrame': 'one year', 'description': 'New low signal intensity lesions on diffusion weighted images on MRI.'}], 'secondaryOutcomes': [{'measure': 'Hematuria', 'timeFrame': 'one year', 'description': 'New hematuria on urine test.'}, {'measure': 'Elevation in Blood Pressure', 'timeFrame': 'one year', 'description': 'Delta of more than 5%'}, {'measure': 'Elevation in Plasma Renin Activity', 'timeFrame': 'one year', 'description': 'Delta of more than 5%'}, {'measure': 'Elevation in Aldosteron level', 'timeFrame': 'one year', 'description': 'Delta of more than 5%'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Renal Infarction']}, 'descriptionModule': {'briefSummary': 'Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve replacement', 'detailedDescription': 'Each patient will undergo Magnetic Resonance assessment of the kidneys before the TAVR. on the third to 7th day after the ATVR, a second MRI to the kidneys will be performed. we will assess the changes and new lesions between both MRI tests and will perform a qualitative and quantitative measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that will be undergoing trans-cather aortic valve replacement for severe symptomatic aortic stenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe symptomatic aortic stenosis\n* Patient is able to lay down supine for 20 min (the time needed to perform the MRI) without any difficulties.\n\nExclusion Criteria:\n\n* Patient is on chronic renal replacement therapy (Dialysis)\n* Documented Thrombus in the left ventricle or left atria'}, 'identificationModule': {'nctId': 'NCT03474250', 'briefTitle': 'Trans-aortic Valve Replacement and Renal Infarction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Trans-catheter Aortic Valve Replacement and Renal Infarction Among Patients With Severe Aortic Stenosis', 'orgStudyIdInfo': {'id': '4887-18'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic Resonance test for kidney', 'type': 'DIAGNOSTIC_TEST', 'description': 'Magnetic Resonance test for kidney'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arwa Younis, Doctor', 'role': 'CONTACT'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Arwa Younis, Doctor', 'role': 'CONTACT', 'email': 'or.younis@gmail.com', 'phone': '0544731936'}], 'overallOfficials': [{'name': 'Arwa Younis, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffesor', 'investigatorFullName': 'Prof. Amit Segev', 'investigatorAffiliation': 'Sheba Medical Center'}}}}