Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study) (BIFF)
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
InSync III
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Dyssynchrony, Cardiac resynchronization therapy, Atrial fibrillation, RVOT, RVapex
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
Sites / Locations
- Heart Centre, Umeå University Hospital
Outcomes
Primary Outcome Measures
quality of life
Secondary Outcome Measures
NYHA class
6-MWT
bi-cycle test
pro-BNP
echocardiographic measures
apnea-hypopnea index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00457834
Brief Title
Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study)
Acronym
BIFF
Official Title
Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
June 2008 (Anticipated)
Study Completion Date
June 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Umeå University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Dyssynchrony, Cardiac resynchronization therapy, Atrial fibrillation, RVOT, RVapex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
InSync III
Intervention Description
Bi-ventricular pacing from leads in LV+RVA or LV+RVOT
Primary Outcome Measure Information:
Title
quality of life
Secondary Outcome Measure Information:
Title
NYHA class
Title
6-MWT
Title
bi-cycle test
Title
pro-BNP
Title
echocardiographic measures
Title
apnea-hypopnea index
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steen M Jensen, MD, PhD
Organizational Affiliation
Heart Centre, Umeå University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Folke Rönn, MD
Organizational Affiliation
Heart Centre, Umeå University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Centre, Umeå University Hospital
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21712261
Citation
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.
Results Reference
derived
Learn more about this trial
Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study)
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