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Ventricular Rate Regularization for Improved Quality of Life in Patients With CHF and AF

Withdrawn
Conditions
Atrial Fibrillation
Congestive Heart Failure
Registration Number
NCT00583921
Lead Sponsor
University of California, Davis
Brief Summary

Single center investigator initiated sponsored by Guidant Boston Scientific Corp. to evaluate the benefit of ventricular rate regularization (VRR) in patients with congestive heart failure (CHF) and significant atrial fibrillation (AF) burden.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Be between 18-85 years old
  • Be willing and able to give informed consent
  • Patient currently has a CRT-D or ICD with > 20% atrial fibrillation burden as recorded by defibrillator follow up report or a history of atrial fibrillation prior to implant.
  • Patient has the ability to complete a Six minute walk test with the only limiting factors to be fatigue or shortness of breath.
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Exclusion Criteria
  • Expected mortality less than 6 months due to non-cardiac causes.
  • Pregnant women.
  • Creatinine greater than or equal to 2.5 mg/dl.
  • Anemia (HCT less than 30)
  • COPD causing significant dyspnea
  • Orthopedic problems affecting 6 minute walk.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms.6 months
Secondary Outcome Measures
NameTimeMethod
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