This trial is active, not recruiting.

Condition heart failure
Treatment insync iii
Phase phase 2
Sponsor Umeå University
Start date November 2003
End date June 2008
Trial size 40 participants
Trial identifier NCT00457834, Um dnr 03-032


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment

Primary Outcomes

quality of life
time frame:

Secondary Outcomes

NYHA class
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bi-cycle test
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echocardiographic measures
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apnea-hypopnea index
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Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation
Principal investigator Steen M Jensen, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by Umeå University.