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

NCT00583921 | Withdrawn DMC

• 1 other identifier: 200614770
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Atrial Fibrillation; ICD; BiV ICD; CHF; Congestive Heart Failure; AF

Outcome Measures

Primary Outcomes (1)

• Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms.

  6 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients implanted with a new Guidant ICD/ CRT-D: Indication for CRT-D and ICD with history of atrial fibrillation. Patients with new implants will not be enrolled until their three month follow up visit in the pacemaker clinic. Patients currenlty implanted with a Guidant ICD/ CRT-D: More than 20% atrial fibrillation burden as recorded by defibrillator follow up report or with history of atrial fibrillation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Guidant Corporation: collaborator

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Uma Srivatsa, MD

  U C Davis Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 2, 2008
• Last Updated: July 13, 2017

Record last verified: 2017-07