Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 4:26 PM
Study NCT ID:
NCT00457834
Status:
UNKNOWN
Last Update Posted:
2008-01-15
First Post:
2007-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2008-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-01-08', 'studyFirstSubmitDate': '2007-04-04', 'studyFirstSubmitQcDate': '2007-04-06', 'lastUpdatePostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life'}], 'secondaryOutcomes': [{'measure': 'NYHA class'}, {'measure': '6-MWT'}, {'measure': 'bi-cycle test'}, {'measure': 'pro-BNP'}, {'measure': 'echocardiographic measures'}, {'measure': 'apnea-hypopnea index'}]}, 'conditionsModule': {'keywords': ['Heart failure', 'Dyssynchrony', 'Cardiac resynchronization therapy', 'Atrial fibrillation', 'RVOT', 'RVapex'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '21712261', 'type': 'DERIVED', 'citation': 'Ronn F, Kesek M, Karp K, Henein M, Jensen SM. Right ventricular lead positioning does not influence the benefits of cardiac resynchronization therapy in patients with heart failure and atrial fibrillation. Europace. 2011 Dec;13(12):1747-52. doi: 10.1093/europace/eur193. Epub 2011 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'Cardiac resynchronization therapy (CRT) is used to treat dilated heart failure with discoordinate contraction. Dyssynchrony typically stems from electrical delay leading to mechanical delay between the septal and lateral walls. Right ventricular apical pacing might be associated with long-term adverse effects on left ventricular function, and alternative pacing sites such as high septal or RVOT has been suggested. Previous studies have however been conflicting. The aim of this study is to determine if bi-ventricular pacing from RVOT + LV is better than RVapex+LV. To avoid influence from possible atrial delay only patients with chronic atrial fibrillation are included. All patients will receive a bi-ventricular pacemaker with 3 leads placed in RVapex, RVOT and via coronary sinus to pace the left ventricle. After a run in period (to determine if AV-junction ablation is necessary) the patients are randomised to one of the following pacing configurations: RVOT+LV or RVapex+LV with cross-over after 3 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart failure NYHA III-IV\n* LVEF\\<35%\n* QRS duration\\>150 ms\n* Chronic atrial fibrillation.\n\nExclusion Criteria:\n\n* Heart failure not related to systolic function\n* Unstable angina pectoris, AMI, PCI or CABG within 2 month\n* Inclusion in other studies'}, 'identificationModule': {'nctId': 'NCT00457834', 'acronym': 'BIFF', 'briefTitle': 'Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study)', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'Um dnr 03-032'}}, 'armsInterventionsModule': {'interventions': [{'name': 'InSync III', 'type': 'DEVICE', 'description': 'Bi-ventricular pacing from leads in LV+RVA or LV+RVOT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Heart Centre, Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Steen M Jensen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Centre, Umeå University Hospital'}, {'name': 'Folke Rönn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Centre, Umeå University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Steen Jensen', 'oldOrganization': 'Heart Centre, Umeå University Hospital and Department of Public Health and Clinical Medicine'}}}}