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OpenTrials
Completed

NCT Number: NCT00146874

CRT RENEWAL Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac resynchronization therapy

Device

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Cardiac Resynchronization Therapy Registry Evaluating Patient Response With RENEWAL Family Devices

Important dates

Study start
2004
Primary completion
2007
First posted
Sep 7, 2005
Registry last updated
Aug 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.