We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00583921
First Posted: January 2, 2008
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Guidant Corporation
Information provided by (Responsible Party):
University of California, Davis
December 26, 2007
January 2, 2008
July 13, 2017
Not Provided
Not Provided
Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms. [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00583921 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ventricular Rate Regularization for Improved Quality of Life in Patients With CHF and AF
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

  • Congestive Heart Failure
  • Atrial Fibrillation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00583921
200614770
Yes
Not Provided
Not Provided
University of California, Davis
University of California, Davis
Guidant Corporation
Principal Investigator: Uma Srivatsa, MD U C Davis Medical Center
University of California, Davis
July 2017