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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by Umeå University. Recruitment status was Active, not recruiting

First Received on April 4, 2007. Last Updated on January 8, 2008 History of Changes

Sponsor:	Umeå University
Information provided by:	Umeå University
ClinicalTrials.gov Identifier:	NCT00457834

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Device: InSync III	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:

quality of life

Secondary Outcome Measures:

NYHA class
6-MWT
bi-cycle test
pro-BNP
echocardiographic measures
apnea-hypopnea index

Estimated Enrollment:	40
Study Start Date:	November 2003
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457834

Locations

Sweden
Heart Centre, Umeå University Hospital
Umeå, Sweden, 901 85

Sponsors and Collaborators

Umeå University

Investigators

Principal Investigator:	Steen M Jensen, MD, PhD	Heart Centre, Umeå University Hospital
Principal Investigator:	Folke Rönn, MD	Heart Centre, Umeå University Hospital

More Information

No publications provided by Umeå University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rönn 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. Epub 2011 Jun 28.

Responsible Party:	Steen Jensen, Heart Centre, Umeå University Hospital and Department of Public Health and Clinical Medicine
ClinicalTrials.gov Identifier:	NCT00457834 History of Changes
Other Study ID Numbers:	Um dnr 03-032
Study First Received:	April 4, 2007
Last Updated:	January 8, 2008
Health Authority:	Sweden: Swedish Research Council

Keywords provided by Umeå University:

Heart failure
Dyssynchrony
Cardiac resynchronization therapy

Atrial fibrillation
RVOT
RVapex

Additional relevant MeSH terms:

Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012