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

Heart Failure Clinical Trial

— BIFF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00457834
• Other study ID #: Um dnr 03-032
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 4, 2007
• Last updated: January 8, 2008
• Start date: November 2003
• Est. completion date: June 2008

Study information

• Verified date: January 2008
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Heart failure NYHA III-IV

• LVEF<35%

• QRS duration>150 ms

• Chronic atrial fibrillation.

Exclusion Criteria:

• Heart failure not related to systolic function

• Unstable angina pectoris, AMI, PCI or CABG within 2 month

• Inclusion in other studies

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Device:
• InSync III
Bi-ventricular pacing from leads in LV+RVA or LV+RVOT

Locations

Country	Name	City	State
Sweden	Heart Centre, Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life
Secondary	NYHA class
Secondary	6-MWT
Secondary	bi-cycle test
Secondary	pro-BNP
Secondary	echocardiographic measures
Secondary	apnea-hypopnea index