CRT RENEWAL Registry

Cardiac Resynchronization Therapy Registry Evaluating Patient Response With RENEWAL Family Devices

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: cardiac resynchronization therapy

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

• Study Type: Observational
• Enrollment: 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Standard CRT population

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Andrew Kaplan, MD, Tri-City Cardiology Consultants

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: September 2, 2005
• First Submitted That Met QC Criteria: September 6, 2005
• First Posted (Estimate): September 7, 2005

Study Record Updates

• Last Update Posted (Estimate): August 18, 2010
• Last Update Submitted That Met QC Criteria: August 17, 2010
• Last Verified: November 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR-CA-042704-H