NCT04200378已完成不适用
Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair
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
- 22
- 试验地点
- 1
- 主要终点
- Change in stroke volume index
研究概览
简要总结
Studying the effects of Trans-catheter Mitral Valve Repair (TMVr) on the hemodynamics and biomarkers in patients with severe mitral valve regurgitation.
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
- •Adults (age ≥ 18 years) with severe, symptomatic primary mitral regurgitation identified by Doppler transthoracic echocardiogram
- •Heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for TMVR with Transcatheter edge to edge repair device.
- •TMVR procedure will be performed in the cardiac catheterization laboratory for hemodynamic data recording
排除标准
- •Women who are pregnant or believe they could be pregnant
结局指标
主要结局
Change in stroke volume index
时间窗: Baseline, approximately 10 mins after valve repair
Change in stroke volume index 10 minutes post repair to baseline stroke volume index measurement (L/m\^2)
Change in cardiac index
时间窗: Baseline, approximately 10 mins after valve repair
Change in cardiac index 10 minutes post repair to baseline cardiac index measurement (L/min/m\^2)
次要结局
未报告次要终点
研究者
Mackram F. Eleid
Principal Investigator
Mayo Clinic
研究点 (1)
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