Evaluation of the Aortic Regurgitation Index (ARi) Measured with the Opsens SavvyWire to Determine the Correlation Between Regurgitation Evaluation Using Echography and Aortography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Opsens, Inc.
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography
研究概览
简要总结
The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography.
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
- •Patients undergoing TAVR suitable for intraoperative acquisition of TEE/TTE
- •Age > 18 years
- •Able and willing to give informed consent.
排除标准
- •Hemodynamic instability making use of additional hemodynamic measurement inappropriate or 24-hour survival unlikely
- •Subject is considered part of a vulnerable population.
结局指标
主要结局
Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography
时间窗: From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours
次要结局
- Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography(From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours)
- Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography(From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours)