CRT RENEWAL Registry

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00146874
First received: September 2, 2005
Last updated: August 17, 2010
Last verified: November 2006
  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 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Resynchronization Therapy Registry Evaluating Patient Response With RENEWAL Family Devices

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Estimated Enrollment: 1000
Study Start Date: May 2004
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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
Sampling Method:   Non-Probability Sample
Study Population

Standard CRT population

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

ClinicalTrials.gov Identifier: NCT00146874     History of Changes
Other Study ID Numbers: CR-CA-042704-H
Study First Received: September 2, 2005
Last Updated: August 17, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014