CRT RENEWAL Registry

This study has been completed.

First Received: September 2, 2005 Last Updated: November 20, 2006 History of Changes

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00146874

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Device: cardiac resynchronization therapy	Phase IV

Study Type:	Observational
Study Design:	Longitudinal, Defined Population, Prospective Study
Official Title:	Cardiac Resynchronization Therapy Registry Evaluating Patient Response With RENEWAL Family Devices

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Estimated Enrollment:	1000
Study Start Date:	May 2004
Estimated Study Completion Date:	July 2006

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146874

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:

Andrew Kaplan, MD

Tri-City Cardiology Consultants

More Information

No publications provided

Study ID Numbers:	CR-CA-042704-H
Study First Received:	September 2, 2005
Last Updated:	November 20, 2006
ClinicalTrials.gov Identifier:	NCT00146874 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 04, 2009