Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study)
This trial is active, not recruiting.
|Start date||November 2003|
|End date||June 2008|
|Trial size||40 participants|
|Trial identifier||NCT00457834, Um dnr 03-032|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
quality of life
Male or female participants from 18 years up to 80 years old.
- Heart failure NYHA III-IV
- QRS duration>150 ms
- Chronic atrial fibrillation.
- Heart failure not related to systolic function
- Unstable angina pectoris, AMI, PCI or CABG within 2 month
- Inclusion in other studies
|Official title||Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation|
|Principal investigator||Steen M Jensen, MD, PhD|
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