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
  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
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

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 April 17, 2014