The HF-HRV Registry

November 13, 2006 updated by: Boston Scientific Corporation

CONTAK RENEWAL® Heart Failure Heart Rate Variability Registry

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

1400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Chair: Kellie Chase, Guidant Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

October 10, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 14, 2006

Last Update Submitted That Met QC Criteria

November 13, 2006

Last Verified

October 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-CA-022103-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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