Ventricular Rate Regularization for Improved Quality of Life in Patients With CHF and AF - Full Text View

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

This study is currently recruiting participants.

Verified by University of California, Davis, June 2008

Sponsors and Collaborators:	University of California, Davis Guidant Corporation
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00583921

Purpose

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.

Condition
Congestive Heart Failure Atrial Fibrillation

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Randomized Study of Ventricular Rate Regularization for Improved Quality of Life in Patients With Congestive Heart Failure and Atrial Fibrillation.

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583921

Contacts

Contact: Melissa Mangum, BS	916-734-7199	melissa.mangum@ucdmc.ucdavis.edu
Contact: Uma Srivatsa, MD	916-734-3764	uma.srivatsa@ucdmc.ucdavis.edu

Locations

United States, California
UC Davis Medical Center	Recruiting
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Guidant Corporation

Investigators

Principal Investigator:

Uma Srivatsa, MD

U C Davis Medical Center

More Information

Clinical Trials at UC Davis Medical Center This link exits the ClinicalTrials.gov site

Responsible Party:	U C Davis Medical Center ( Uma Srivatsa, MD )
Study ID Numbers:	200614770
Study First Received:	December 26, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00583921
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Atrial Fibrillation
ICD
BiV ICD

CHF
Congestive Heart Failure
AF

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Quality of Life
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009