Ventricular Rate Regularization for Improved Quality of Life in Patients With CHF and AF
Withdrawn
- Conditions
- Atrial FibrillationCongestive 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- WITHDRAWN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
Name Time Method Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms. 6 months
- Secondary Outcome Measures
Name Time Method