NCT03923673已完成不适用
TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiac and Cerebrovascular Events
研究概览
简要总结
Researchers are studying the safety and efficacy of a minimally invasive treatment called a pericardiotomy, which creates a small opening in the sac that surrounds the heart. Researchers will test the short and long term effects of this procedure by monitoring subjects heart function and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Major Adverse Cardiac and Cerebrovascular Events
时间窗: 6 months
The number of major cardiac and cerebrovascular events reported.
Change in left ventricular filling pressures during volume loading
时间窗: baseline, 6 months
The number of subjects to demonstrate an increase in pulmonary capillary wedge pressure in response to volume loading after pericardiotomy vs. prior to pericardiotomy.
次要结局
- Change in Quality of Life(baseline, 6 months)
- Change in exercise capacity(baseline, 6 months)
研究者
Barry Borlaug
Principal Investigator
Mayo Clinic
研究点 (2)
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