The HF-HRV Registry

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. Identifier: NCT00236236
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : November 14, 2006
Information provided by:
Boston Scientific Corporation

Brief Summary:
The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization therapy in patients with heart failure.

Condition or disease Intervention/treatment
Heart Failure Arrhythmia Device: Cardiac Resynchronization Therapy

Study Type : Observational
Enrollment : 1400 participants
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: CONTAK RENEWAL® Heart Failure Heart Rate Variability Registry
Study Start Date : February 2003
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients receiving their first CRT-D
  • Patients who sign and date a Patient Informed Consent prior to device implant
  • Patients who are available and willing to attend follow-up visits at the study center in which they were enrolled

Exclusion Criteria:

  • Patients who are anticipated to receive pacing modes other than DDD or VDD (i.e., chronic atrial fibrillation patients are excluded), or patients who are anticipated to receive adaptive rate therapy
  • Patients who are younger than 18 years of age
  • Patients whose life expectancy is less than six-months due to other medical conditions
  • Patients with or who are likely to receive a tricuspid or other valve prosthesis
  • Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
  • Women who are pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00236236

Sponsors and Collaborators
Boston Scientific Corporation
Study Chair: Kellie Chase Guidant Corporation Identifier: NCT00236236     History of Changes
Other Study ID Numbers: CR-CA-022103-H
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: November 14, 2006
Last Verified: October 2005

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases