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This study has been withdrawn prior to enrollment.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

December 26, 2007
March 26, 2013
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Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00583921 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00583921
200614770
Yes
Uma Srivatsa, MD, University of California, Davis
University of California, Davis
Guidant Corporation
Principal Investigator: Uma Srivatsa, MD U C Davis Medical Center
University of California, Davis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP