Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-03-22 @ 12:44 PM
Study NCT ID:
NCT04053192
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2019-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of BAV in Different Hemodynamic Entities of Severe AS
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2019-08-07', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Mortality', 'timeFrame': '1-Year post BAV'}, {'measure': 'Post-Procedure Hemodynamic Changes', 'timeFrame': '24 - 72 h after procedure', 'description': 'dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR'}], 'secondaryOutcomes': [{'measure': 'Number of patients with myocardial infarction', 'timeFrame': '30 days after intervention', 'description': 'Evaluation by using the VARC-2 definition'}, {'measure': 'Number of patients with stroke', 'timeFrame': '30 days after intervention', 'description': 'Evaluation by using the VARC-2 definition'}, {'measure': 'Number of patients with bleeding complications', 'timeFrame': '30 days after intervention', 'description': 'Evaluation by using the VARC-2 definition'}, {'measure': 'Number of patients with acute kidney injury', 'timeFrame': '30 days after intervention', 'description': 'Evaluation by using the VARC-2 definition'}, {'measure': 'Number of patients with vascular complications', 'timeFrame': '30 days after intervention', 'description': 'Evaluation by using the VARC-2 definition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balloon Aortic Valvuloplasty', 'Severe Aortic Valve Stenosis', 'Surgical aortic valve replacement (SAVR)'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.', 'detailedDescription': 'The Balloon Aortic Valvuloplasty (BAV) is a catheter-based intervention, which can be used for dilatation of serve aortic stenosis. With this minimally invasive intervention an increase of the aortic valve area (AVA) and cardiac ejection fraction (EF), decrease of transvalvular gradients and ultimately a symptom relief should be achieved. The required effect is temporary and a definitive treatment should be aspired in suitable patients. Therefor Transcatheter Aortic Valve Replacement (TAVR) is available.\n\nFollowing the guidelines of the European Society of Cardiology for the management of valvular heart disease from 2017, the aortic stenosis can be divided into different subtypes by using haemodynamic parameters: High-gradient AS (HG-AS), Low-Flow-Low-Gradient AS (LFLG-AS) and paradoxical Low-Flow-Low-Gradient (pLFLG-AS). Patients with LFLG-AS are suspected to have a poorer prognosis when treated curative as well as when treated palliative medicamentous, because these patients show coronary and myocardial restrictions more frequently in addition to the valvular disease.\n\nThe aim of the study is to compare safety and effectiveness of balloon aortic valvuloplasty as a bridging therapy and transcatheter aortic valve replacement as a definitive treatment in HG-AS, LFLG-AS and pLFLG-AS patients to verify whether the subtypes of aortic stenosis profit equally from these interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '97 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the heart failure program of the University of Duesseldorf', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Severe Aortic Stenosos who underwent BAV\n\nExclusion Criteria:\n\n* insufficient echocardiographic parameters before BAV'}, 'identificationModule': {'nctId': 'NCT04053192', 'acronym': 'BAV', 'briefTitle': 'Evaluation of BAV in Different Hemodynamic Entities of Severe AS', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis', 'orgStudyIdInfo': {'id': '19-003 BAV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High-Gradient Aortic Stenosis (HG-AS)', 'description': '(Pmean \\>40mmHg, AVA \\<1cm\\^2, Vmax \\>4m/s)', 'interventionNames': ['Procedure: BAV', 'Procedure: BAV + TAVR', 'Procedure: SAVR']}, {'label': 'Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)', 'description': '(Pmean \\<40mmHg, AVA \\<1cm\\^2, Vmax \\<4m/s, EF \\<50%)', 'interventionNames': ['Procedure: BAV', 'Procedure: BAV + TAVR', 'Procedure: SAVR']}, {'label': 'Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)', 'description': 'Pmean \\<40mmHg, AVA \\<1cm\\^2, Vmax \\< 4m/s, EF \\>50%)', 'interventionNames': ['Procedure: BAV', 'Procedure: BAV + TAVR', 'Procedure: SAVR']}], 'interventions': [{'name': 'BAV', 'type': 'PROCEDURE', 'description': 'BAV', 'armGroupLabels': ['High-Gradient Aortic Stenosis (HG-AS)', 'Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)', 'Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)']}, {'name': 'BAV + TAVR', 'type': 'PROCEDURE', 'description': 'BAV + TAVR', 'armGroupLabels': ['High-Gradient Aortic Stenosis (HG-AS)', 'Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)', 'Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)']}, {'name': 'SAVR', 'type': 'PROCEDURE', 'description': 'Surgical aortic valve replacement (SAVR)', 'armGroupLabels': ['High-Gradient Aortic Stenosis (HG-AS)', 'Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)', 'Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Tobias Zeus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}