NCT00146874已完成不适用
Cardiac Resynchronization Therapy Registry Evaluating Patient Response With RENEWAL Family Devices
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
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