Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- All-Cause Mortality
研究概览
简要总结
MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality.
(MADIT-CRT IDE: NCT00180271)
详细描述
The registry is designed to determine the long-term mortality benefit as a result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The registry will collect data on patients that previously participated at MADIT-CRT sites within the US through five years of participation from their orginal enrollment in the MADIT-CRT IDE study (MADIT-CRT IDE: NCT00180271).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active patients who were enrolled in the MADIT-CRT IDE (NCT00180271)within the United States
排除标准
- •Patients who are unable or unwilling to comply with the protocol requirements
结局指标
主要结局
All-Cause Mortality
时间窗: 5 years
Outcome measured for total population. Not broken down by indication received.
次要结局
未报告次要终点