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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 or disease
Device: cardiac resynchronization therapy
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Standard CRT population
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
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