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The HF-HRV Registry

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00236236
First received: September 2, 2005
Last updated: November 13, 2006
Last verified: October 2005
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236236

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

No publications provided

ClinicalTrials.gov Identifier: NCT00236236     History of Changes
Other Study ID Numbers: CR-CA-022103-H
Study First Received: September 2, 2005
Last Updated: November 13, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013