Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-01 @ 1:14 PM
Study NCT ID:
NCT04385459
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2020-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568331', 'term': 'JCAD protein, mouse'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Five years.', 'description': 'Death after the procedure'}], 'secondaryOutcomes': [{'measure': 'Factors associated with less favorable early and late mortality', 'timeFrame': 'Five years', 'description': 'Factors such as renal function or comorbidities associated with higher mortality.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic valve stenosis', 'Coronary artery disease', 'Transcatheter aortic valve implantation', 'Mortality'], 'conditions': ['Aortic Valve Stenosis', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.', 'detailedDescription': "A narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the elderly. When the narrowing gets too severe, symptoms such as loss of breath, angina and fainting can occur, so called symptomatic aortic stenosis. Since the 60's, surgical aortic valve replacement (sAVR) has been the treatment of choice for severe aortic stenosis. A large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk.\n\nTranscatheter aortic valve implantation (TAVI) have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade. The procedure, which is a minimal invasive type of surgery, introduces a new aortic valve through a catheter, usually transfemorally. Patients with an underlying coronary artery disease (CAD) undergoing sAVR is known to have higher mortality rates postoperatively. However, it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery. It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that underwent a TAVI procedure at Örebro University Hospital between the time period 2009 till 1st december 2019 were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients that underwent a TAVI procedure at Örebro University Hospital between 2009 till 1st december 2019.\n\nExclusion Criteria:\n\n* Patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04385459', 'briefTitle': 'Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Örebro County Council'}, 'officialTitle': 'Long Term Follow-up (=> 5 Years) for Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease', 'orgStudyIdInfo': {'id': '273468'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients without coronary artery disease', 'description': 'No prior coronary intervention and no significant stenosis noted during coronary angiography.'}, {'label': 'Patients with coronary artery disease', 'description': 'Our definition of coronary artery disease is:\n\n* Prior coronary artery bypass grafting or percutaneous coronary intervention\n* Significant stenosis or occlusion noted during coronary angiography', 'interventionNames': ['Other: Coronary artery disease']}], 'interventions': [{'name': 'Coronary artery disease', 'type': 'OTHER', 'description': 'Exposure', 'armGroupLabels': ['Patients with coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Ninos Samano, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiothoracic and Vascular Surgery, Örebro University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro County Council', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ninos Samano M.D.', 'investigatorAffiliation': 'Örebro County Council'}}}}