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

July 10, 2017 updated by: University of California, Davis

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms. Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Guidant Corporation

Investigators

Principal Investigator: Uma Srivatsa, MD, U C Davis Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

200614770

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.