A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 15
- 主要终点
- Subject's average mean gradient measurement over time
研究概览
简要总结
Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.
详细描述
Subjects in the INDICATE registry study will be enrolled at up to 20 sites in Germany. Up to 500 subjects will be implanted with the INSPIRIS RESILIA Aortic Valve in this registry.
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 requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose
- •Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available
- •Age ≥ 18 years
- •Provision of written informed consent
排除标准
- •Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
- •Emergency procedure
- •Patients requiring a non-aortic heart valve procedure during the index procedure
研究组 & 干预措施
Edwards INSPIRIS RESILIA Aortic Valve
Subjects who were treated with the INSPIRIS RESILIA Aortic Valve
干预措施: Edwards INSPIRIS RESILIA Aortic Valve (Device)
结局指标
主要结局
Subject's average mean gradient measurement over time
时间窗: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Subject's average peak gradient measurement over time
时间窗: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Amount of aortic transvalvular regurgitation in subjects over time
时间窗: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed by four categories, which are "no/trace leak", "a mild leak", "a moderate leak", and "a severe leak". A severe leak indicates a worsening outcome.
Amount of aortic paravalvular regurgitation in subjects over time
时间窗: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed by four categories, which are "no/trace leak", "a mild leak", "a moderate leak", and "a severe leak". A severe leak indicates a worsening outcome.
次要结局
- Subject's New York Heart Association (NYHA) functional classification at 3 months as compared to baseline.(Baseline and 3 months)