Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01081093
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2010-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2010-03-04', 'studyFirstSubmitQcDate': '2010-03-04', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction', 'Biventricular Pacemaker cardiac surgery aortic valve replacement'], 'conditions': ['Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure.\n\nA temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure.\n\nThe investigators propose that biventricular pacing in these patients and conditions results in an improvement of symptoms instead of single right pacing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years\n* Hypertrophic Cardiomyopathy\n* Aortic valve replacement\n\nExclusion Criteria:\n\n* Atrial fibrillation\n* Pericarditis\n* postoperative low output\n* Preoperative permanent pacemaker placement'}, 'identificationModule': {'nctId': 'NCT01081093', 'acronym': 'BIVENT', 'briefTitle': 'Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement', 'orgStudyIdInfo': {'id': 'Bivent001AR-AHK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biventricular pacing', 'interventionNames': ['Procedure: additional temporary pacewire']}], 'interventions': [{'name': 'additional temporary pacewire', 'type': 'PROCEDURE', 'description': 'Placement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy', 'armGroupLabels': ['Biventricular pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Johann Wolfgang Goethe Universitätsklinikum', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Arndt-H. Kiessling', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}