Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study)
BIFF
Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 heart-failure
Started Nov 2003
Longer than P75 for phase_2 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 4, 2007
CompletedFirst Posted
Study publicly available on registry
April 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJanuary 15, 2008
January 1, 2008
4.6 years
April 4, 2007
January 8, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
quality of life
Secondary Outcomes (6)
NYHA class
6-MWT
bi-cycle test
pro-BNP
echocardiographic measures
- +1 more secondary outcomes
Interventions
Bi-ventricular pacing from leads in LV+RVA or LV+RVOT
Eligibility Criteria
You may qualify if:
- Heart failure NYHA III-IV
- LVEF\<35%
- QRS duration\>150 ms
- Chronic atrial fibrillation.
You may not qualify if:
- Heart failure not related to systolic function
- Unstable angina pectoris, AMI, PCI or CABG within 2 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Study Sites (1)
Heart Centre, Umeå University Hospital
Umeå, 901 85, Sweden
Related Publications (1)
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.
PMID: 21712261DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steen M Jensen, MD, PhD
Heart Centre, Umeå University Hospital
- PRINCIPAL INVESTIGATOR
Folke Rönn, MD
Heart Centre, Umeå University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 4, 2007
First Posted
April 9, 2007
Study Start
November 1, 2003
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
January 15, 2008
Record last verified: 2008-01