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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00457834
Acronym
BIFF
Enrollment
40
Registered
2007-04-09
Start date
2003-11-30
Completion date
2008-06-30
Last updated
2008-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Dyssynchrony, Cardiac resynchronization therapy, Atrial fibrillation, RVOT, RVapex

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.

Interventions

DEVICEInSync III

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

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
quality of life

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026