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

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ClinicalTrials.gov Identifier: NCT00457834
Recruitment Status : Unknown
Verified January 2008 by Umeå University.
Recruitment status was:  Active, not recruiting
First Posted : April 9, 2007
Last Update Posted : January 15, 2008
Sponsor:
Information provided by:
Umeå University

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: InSync III Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2003
Estimated Primary Completion Date : June 2008
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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


Primary Outcome Measures :
  1. quality of life

Secondary Outcome Measures :
  1. NYHA class
  2. 6-MWT
  3. bi-cycle test
  4. pro-BNP
  5. echocardiographic measures
  6. apnea-hypopnea index


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: April 9, 2007    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008

Keywords provided by Umeå University:
Heart failure
Dyssynchrony
Cardiac resynchronization therapy
Atrial fibrillation
RVOT
RVapex

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes