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
Sponsor:
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT00457834
First received: April 4, 2007
Last updated: January 8, 2008
Last verified: January 2008
  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 2

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:


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:
    Device: InSync III
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 July 23, 2014