The Society of Thoracic Surgeons and American College of Cardiology Foundation's Transcutaneous Valve Therapy (TVT) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebrovascular events
研究概览
简要总结
The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies.
详细描述
The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry.
The secondary aim of the TVT Registry is to serve as a scalable data infrastructure forpost market studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Adult patients (age 18 and older) who undergo an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.
排除标准
- 未提供
结局指标
主要结局
Major adverse cardiac and cerebrovascular events
时间窗: 30 days from procedure
increase in the 30-day risk of adverse events among patients receiving TAVR
次要结局
- Mortality(1 year)
- Major adverse cardiac and cerebrovascular events(1 year from procedure)
研究者
Colleen Balius
CLINICAL DATA COORDINATOR (RN)
Hoag Memorial Hospital Presbyterian
