Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-29 @ 10:47 PM
Study NCT ID:
NCT00746135
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2008-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2008-08-20', 'studyFirstSubmitQcDate': '2008-09-02', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement according to Packer\'s "Heart Failure Clinical Composite Respond"', 'timeFrame': '12 months post implant'}], 'secondaryOutcomes': [{'measure': 'Intraoperative Increase in Left Ventricular dp/dt', 'timeFrame': 'At Implant'}, {'measure': 'Cardiopulmonary Capacity(Spiroergometry)', 'timeFrame': '12 months'}, {'measure': 'Change in B-type natriuretic Peptide (BNP)-Concentration', 'timeFrame': '12 months'}, {'measure': '6 min walk test', 'timeFrame': '12 months'}, {'measure': 'QoL assessment("Minnesota Living with Heart Failure = MLHF)', 'timeFrame': '12 months'}, {'measure': '12 channel ECG', 'timeFrame': '12 months'}, {'measure': '2D-echo optimized EF', 'timeFrame': '12 months'}, {'measure': 'Complications and morbidity', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart failure (NYHA class III and IV)', 'Ventricular Dyssynchrony'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': "It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and CRT timing on the outcome of cardiac resynchronization therapy (CRT)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with indication for CRT-D: NYHA III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure\n* LVEDD \\> 55 mm or \\> 30 mm/m² BSA\n* EF \\< 35%\n* Sinus rhythm and one of the following criteria:\n* QRS \\>= 120 ms and PQ \\>= 200ms\n* or\n* 2nd / 3rd degree AV block\n* Written informed consent\n\nExclusion Criteria:\n\n* pacemaker indication (without ICD indication)\n* tricuspidal valve and/or aortic valve replacement\n* Indication for revascularization.\n* less than 3 month after heart surgery or myocardial infarction\n* hypertrophic obstructive cardiomyopathy\n* intravenous catecholamine treatment\n* uncorrected thyroid function\n* severe kidney disorder (creatinin \\>2,5mg%)\n* no written patient consent\n* insufficient patient compliance\n* participating in another study\n* life expectancy \\< 1 year due to other severe disease\n* age \\< 18 years\n* no contraception (young women) or pregnancy'}, 'identificationModule': {'nctId': 'NCT00746135', 'acronym': 'TRI-V', 'briefTitle': 'TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'TRI-V Resynchronization in Paced Heart Failure Patients With ICD Indication.', 'orgStudyIdInfo': {'id': 'H37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Conventional Biventricular Stimulation: RV Apex and LV Lead Tip', 'interventionNames': ['Device: Device Implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V".', 'interventionNames': ['Device: Device Implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'description': 'Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His', 'interventionNames': ['Device: Device Implantation']}], 'interventions': [{'name': 'Device Implantation', 'type': 'DEVICE', 'otherNames': ['CRT-D Devices:', 'Atlas™ II+ HF / V-367 /St. Jude Medical', 'Epic™ II+ HF / V-357 / St. Jude Medical', 'Promote™ / 3207-36 / 3213-36 / St. Jude Medical', 'Adapters:', 'VIS 16 / Dr. Osypka GmbH'], 'description': 'RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation', 'armGroupLabels': ['A', 'B', 'C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49214', 'city': 'Bad Rothenfelde', 'country': 'Germany', 'facility': 'Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde', 'geoPoint': {'lat': 52.11667, 'lon': 8.16667}}], 'overallOfficials': [{'name': 'Wolfgang Kranig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}