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

This study has been withdrawn prior to enrollment.
(no subjects enrolled)
Sponsor:
Collaborator:
Guidant Corporation
Information provided by (Responsible Party):
Uma Srivatsa, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00583921
First received: December 26, 2007
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 0
  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

Sponsors and Collaborators
University of California, Davis
Guidant Corporation
Investigators
Principal Investigator: Uma Srivatsa, MD U C Davis Medical Center
  More Information

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

No publications provided

Responsible Party: Uma Srivatsa, MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00583921     History of Changes
Other Study ID Numbers: 200614770
Study First Received: December 26, 2007
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Atrial Fibrillation
ICD
BiV ICD
 CHF
Congestive Heart Failure
AF

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013