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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Uma Srivatsa, MD, University of California, Davis
First received: December 26, 2007
Last updated: March 26, 2013
Last verified: March 2013
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.
Congestive Heart Failure
||Observational Model: Cohort
Time Perspective: Prospective
||Randomized Study of Ventricular Rate Regularization for Improved Quality of Life in Patients With Congestive Heart Failure and Atrial Fibrillation.
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 ]
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583921
University of California, Davis
||Uma Srivatsa, MD
||U C Davis Medical Center
No publications provided
||Uma Srivatsa, MD, Principal Investigator, University of California, Davis
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 26, 2007
||March 26, 2013
||United States: Institutional Review Board
Keywords provided by University of California, Davis:
Congestive Heart Failure
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013