Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT00387803
Status:
COMPLETED
Last Update Posted:
2007-01-25
First Post:
2006-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058406', 'term': 'Cardiac Resynchronization Therapy'}, {'id': 'D004554', 'term': 'Electric Countershock'}], 'ancestors': [{'id': 'D002304', 'term': 'Cardiac Pacing, Artificial'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 581}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-02'}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2001-08'}, 'lastUpdateSubmitDate': '2007-01-23', 'studyFirstSubmitDate': '2006-10-11', 'studyFirstSubmitQcDate': '2006-10-11', 'lastUpdatePostDateStruct': {'date': '2007-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia'}], 'secondaryOutcomes': [{'measure': 'Peak VO2'}, {'measure': 'NYHA Class'}, {'measure': 'Six minute walk distance'}, {'measure': 'Quality of life'}, {'measure': 'Echocardiographic measures'}]}, 'conditionsModule': {'conditions': ['Heart Failure, Congestive', 'Ventricular Fibrillation', 'Tachycardia, Ventricular']}, 'referencesModule': {'references': [{'pmid': '14563591', 'type': 'RESULT', 'citation': 'Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA, Boehmer JP, Higginbotham MB, De Marco T, Foster E, Yong PG. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol. 2003 Oct 15;42(8):1454-9. doi: 10.1016/s0735-1097(03)01042-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.', 'detailedDescription': 'Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic heart failure\n* Left ventricular ejection fraction \\<= 35%\n* QRS width \\>= 120 ms\n* Indicated for an implantable cardioverter defibrillator\n\nExclusion Criteria:\n\n* Indicated for a pacemaker\n* Atrial tachyarrhythmias'}, 'identificationModule': {'nctId': 'NCT00387803', 'briefTitle': 'Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'VENTAK CHF/CONTAK CD Biventricular Pacing Study', 'orgStudyIdInfo': {'id': 'Clinicals0010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac Resynchronization Therapy with Defibrillation', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55112', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Multiple locations', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Steven Higgins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Memorial Hospital'}, {'name': 'Leslie A Saxon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California San Francisco Medical Center'}, {'name': 'John Boehmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}, {'name': 'Teresa De Marco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California San Francisco Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}}}}