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

NCT ID: NCT00583921

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL

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.

Conditions

Congestive Heart Failure; Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guidant Corporation

INDUSTRY

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uma Srivatsa, MD

Role: PRINCIPAL_INVESTIGATOR

U C Davis Medical Center

Other Identifiers

200614770

Identifier Type: -

Identifier Source: org_study_id