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Clinical Trials/NCT00457834
NCT00457834
Unknown
Phase 2

Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation

Umeå University1 site in 1 country40 target enrollmentNovember 2003
ConditionsHeart Failure

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Umeå University
Enrollment
40
Locations
1
Primary Endpoint
quality of life
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2003
End Date
June 2008
Last Updated
18 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

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

Outcomes

Primary Outcomes

quality of life

Secondary Outcomes

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

Study Sites (1)

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