The HF-HRV Registry - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00236236

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 IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Heart Failure

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

Further study details as provided by Boston Scientific Corporation:

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

Eligibility

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

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

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009