The HF-HRV Registry

Heart Failure Clinical Trial

Official title:

CONTAK RENEWAL® Heart Failure Heart Rate Variability Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236236
• Other study ID #: CR-CA-022103-H
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2005
• Last updated: November 13, 2006
• Start date: February 2003
• Est. completion date: May 2005

Study information

• Verified date: October 2005
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Arrhythmia
• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation