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NCT00583921 Clinical Trial

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

Atrial Fibrillation Clinical Trial

— VRR  

Official title:
Randomized Study of Ventricular Rate Regularization for Improved Quality of Life in Patients With Congestive Heart Failure and Atrial Fibrillation.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00583921
Other study ID # 200614770
Secondary ID
Status Withdrawn
Phase N/A
First received December 26, 2007
Last updated July 10, 2017

Study information
Verified date July 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of California, Davis Guidant Corporation

Outcome
Type Measure Description Time frame Safety issue
Primary Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms. 6 months
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