NCT03191656进行中（未招募）不适用
A Post-Market Clinical Follow-up Study to Evaluate the Corvia Medical, Inc. InterAtrial Shunt Device - IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Corvia Medical54 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2017年3月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 54
- 主要终点
- Serious Adverse Events
研究概览
简要总结
This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a "real world" practice setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This is a post market registry so no criteria requirements (only recommendations).
排除标准
- 未提供
结局指标
主要结局
Serious Adverse Events
时间窗: 30 days
Device and or procedure related serious adverse cardiac events
Quality of Life Improvement (EQ5D)
时间窗: 12 months
Improvement in EQ5D score
Quality of Life Improvement (KCCQ score)
时间窗: 12 months
Improvement in KCCQ score
New York Heart Classification
时间窗: 12 months
Improvement in NYHA Classification
次要结局
未报告次要终点
研究者
研究点 (54)
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