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

NCT ID: NCT00457834

Last Updated: 2008-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2008-06-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Interventions

InSync III

Bi-ventricular pacing from leads in LV+RVA or LV+RVOT

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Heart Centre, Umeå University Hospital and Department of Public Health and Clinical Medicine

Principal Investigators

Steen M Jensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Centre, Umeå University Hospital

Folke Rönn, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Centre, Umeå University Hospital

Locations

Heart Centre, Umeå University Hospital

Umeå, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 21712261 (View on PubMed)

Other Identifiers

Um dnr 03-032

Identifier Type: -

Identifier Source: org_study_id