The HF-HRV Registry

Completed

• Conditions: Heart Failure; Arrhythmia

• Registration Number: NCT00236236
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study Completion: 2005-05
• Study First Submitted: 2005-09-02
• Status Verified: 2005-10
• Study First Submitted QC: 2005-10-10
• Study First Posted: 2005-10-12
• Last Update Submitted: 2006-11-13
• Last Update Posted: 2006-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified