NCT00457834

Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study)

Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	InSync III	Bi-ventricular pacing from leads in LV+RVA or LV+RVOT

Timeline

• Start date: 2003-11-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-04-09
• Last updated: 2008-01-15

Locations

1 site across 1 country: Sweden