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The HF-HRV Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00236236
First Posted: October 12, 2005
Last Update Posted: November 14, 2006
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.
Information provided by:
Boston Scientific Corporation
  Purpose
The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization therapy in patients with heart failure.

Condition Intervention Phase
Heart Failure Arrhythmia Device: Cardiac Resynchronization Therapy Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: CONTAK RENEWAL® Heart Failure Heart Rate Variability Registry

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Estimated Enrollment: 1400
Study Start Date: February 2003
Estimated Study Completion Date: May 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00236236


Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Chair: Kellie Chase Guidant Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00236236     History of Changes
Other Study ID Numbers: CR-CA-022103-H
First Submitted: September 2, 2005
First Posted: October 12, 2005
Last Update Posted: November 14, 2006
Last Verified: October 2005

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases