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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by Umeå University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457834
First Posted: April 9, 2007
Last Update Posted: January 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Umeå University
April 4, 2007
April 9, 2007
January 15, 2008
November 2003
June 2008   (Final data collection date for primary outcome measure)
quality of life
Same as current
Complete list of historical versions of study NCT00457834 on ClinicalTrials.gov Archive Site
  • NYHA class
  • 6-MWT
  • bi-cycle test
  • pro-BNP
  • echocardiographic measures
  • apnea-hypopnea index
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
Device: InSync III
Bi-ventricular pacing from leads in LV+RVA or LV+RVOT
Not Provided
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. doi: 10.1093/europace/eur193. Epub 2011 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00457834
Um dnr 03-032
Not Provided
Not Provided
Not Provided
Steen Jensen, Heart Centre, Umeå University Hospital and Department of Public Health and Clinical Medicine
Umeå University
Not Provided
Principal Investigator: Steen M Jensen, MD, PhD Heart Centre, Umeå University Hospital
Principal Investigator: Folke Rönn, MD Heart Centre, Umeå University Hospital
Umeå University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP