CRT RENEWAL Registry

NCT ID: NCT00146874

Last Updated: 2010-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-05-31

Brief Summary

This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure hospitalization, NYHA class, and quality of life.

Detailed Description

The CRT RENEWAL Registry aims to characterize patient demographics and clinical attributes at enrollment and overall event rates as defined by heart failure decompensation, heart failure hospitalization, death, and ventricular arrhythmic events. The registry will also assess clinical outcomes including quality of life (QOL), physical activity habits, and events rates, along with device diagnostics such as Activity Log Index and heart rate

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

cardiac resynchronization therapy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who meet current indications for the CONTAK RENEWAL® family of CRT-P or CRT-D devices
• Patients who receive either transvenous Guidant manufactured ventricular leads or non-Guidant epicardial leads
• Patients who have had an ejection fraction measured within six months of enrollment
• Patients who sign and date a Patient Informed Consent form at the enrollment visit
• Patients who remain in the clinical care of the enrolling physician in approved centers

Exclusion Criteria

• Patients who are expected to receive a heart transplant during the duration of the registry
• Patients who currently have or who are likely to receive a tricuspid valve prosthesis
• Patients who are currently enrolled in another observational registry or investigational study that would directly impact the treatment or outcome of the CRT RENEWAL Registry. Each instance will be brought to the attention of Guidant's Clinical Application Research Studies (CARS) Department to determine eligibility
• Patients who are younger than 18 years of age
• Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the registry
• Patients who are pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

Andrew Kaplan, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-City Cardiology Consultants

Other Identifiers

CR-CA-042704-H

Identifier Type: -

Identifier Source: org_study_id