Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-03 @ 9:00 AM
Study NCT ID:
NCT00986193
Status:
TERMINATED
Last Update Posted:
2017-06-01
First Post:
2009-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'whyStopped': 'By recommendation from the Data and safety monitoring board', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-31', 'studyFirstSubmitDate': '2009-09-25', 'studyFirstSubmitQcDate': '2009-09-28', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death, CVI and/or renal failure requiring any dialysis', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Echocardiographic results, valve performance', 'timeFrame': '1 month with subseguent followup'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aortic Valve Stenosis', 'Stent Valve', 'Biological Aortic Valve Prosthesis'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.', 'detailedDescription': 'The purpose of the study is to compare the new established apical stent valve treatment with conventional surgical intervention using biological valve prostheses in patients with severe aortic valve stenosis.\n\nThe Edwards-SAPIENTM Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) will be used in the stent valve group. The Carpentier-Edwards-Perimount Heart Valve (Edwards Lifesciences, Irvine, CA) will be recommended for the conventional surgery group.(Edwards Lifesciences, Irvine, CA).\n\nHeart centres in the Nordic region with experience (\\>10 cases) in apical stent valve treatment and in conventional surgical treatment of high risk patients with aortic valve stenosis. The study will be initiated at Aarhus University Hospital, Skejby, Denmark.\n\nStudy hypothesis:\n\nAs compared to conventional aortic valve substitution in patients aged \\>75 years, apical stent valve treatment reduces the rates of death, cerebrovascular insult (CVI) and need of dialysis for renal failure 1 month after the treatment.\n\nPrimary clinical end-point:\n\nCombined end-point consisting of death, CVI and/or renal failure with need for haemodialysis, 1 month after index treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Significant aortic valve stenosis (valve area \\< 1cm2)\n* Age \\> 75 (years Aarhus University Hospital, Skejby)\n* Age \\> 80 years (other participating centres)\n* Operable by conventional surgery AND transapical stent valve implantation\n* Expected survival \\> 1 year following successful treatment\n* Accept of participation and in follow-up investigations after adequate information\n* Informed consent\n\nExclusion Criteria:\n\n* Coronary artery disease requiring PCI or CABG\n* Earlier cardiac surgery\n* Myocardial infarction within 24 hours\n* Kidney failure requiring any dialysis\n* Ongoing infection\n* Acute surgery\n* Allergy to ASA or Clopidogrel'}, 'identificationModule': {'nctId': 'NCT00986193', 'briefTitle': 'Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital Skejby'}, 'officialTitle': 'Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis', 'orgStudyIdInfo': {'id': 'Skejby 2008-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Aortic Valve Surgery', 'description': 'Insertion of a biological valve', 'interventionNames': ['Procedure: Conventional Aortic Valve Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Transapical Aortic Valve Implantation', 'description': 'Transapical implantation of an Edwards SAPIENtm valve', 'interventionNames': ['Procedure: Transapical Aortic Valve Implantation']}], 'interventions': [{'name': 'Transapical Aortic Valve Implantation', 'type': 'PROCEDURE', 'description': 'Insertion of a stent valve using catheter-based technique through a mini thoracotomy', 'armGroupLabels': ['Transapical Aortic Valve Implantation']}, {'name': 'Conventional Aortic Valve Surgery', 'type': 'PROCEDURE', 'description': 'Operation using heart-lung machine, with insertion of a biological artificial heart valve', 'armGroupLabels': ['Conventional Aortic Valve Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, Skejby', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'overallOfficials': [{'name': 'Evald H Christiansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skejby Hospital, Aarhus, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital Skejby', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Danish Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Evald Hoej Christiansen', 'investigatorAffiliation': 'Aarhus University Hospital Skejby'}}}}