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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Conditions
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
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.
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