Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 21
- 主要终点
- Time-related valve safety
研究概览
简要总结
Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.
详细描述
The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.
The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model. In this registry, data is collected over a period of 5 years to demonstrate these properties in a clinical real-life setting. Clinical outcomes, hemodynamic as well as safety parameters and quality of life data are documented into e-CRF at baseline, surgery, pre-discharge, 3-6 months and annually up to year 5.
The required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. It was estimated, from COMMENCE Trial dataset that freedom from time-related valve safety events at 1 year (composite endpoint according to VARC-2) is around 0.915. The following table illustrates 95% CIs at different levels of risk:
Sample Size Observed freedom from event 95%CI 400 0.900 ± 0.0294 400 0.910 ± 0.0280 400 0.915 ± 0.0214 400 0.920 ± 0.0266 400 0.930 ± 0.0250
20% of registry sites will be monitored with 100% source data verification
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years inclusive
- •Subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation
- •Subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery
- •Subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up
- •Subject provides written informed consent prior to the procedure
排除标准
- •Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
- •Previous aortic valve replacement
- •Valve implantation is not possible in accordance with the device IFU
- •Subject has a life expectancy ≤ 12 months for any reason
- •Intraoperative Exclusion criteria:
- •Valve implantation is not possible in accordance with the device IFU
结局指标
主要结局
Time-related valve safety
时间窗: Year 1
Composite endpoint according to VARC-2 depicted as freedom from event: * SVD (structural valve deterioration) * Valve-related dysfunction * Requirement of repeat procedure * Prosthetic valve endocarditis * Prosthetic valve thrombosis * Thromboembolic events (e.g. stroke) * Valve-related VARC bleeding
Freedom from severe SVD (structural valve deterioration)
时间窗: Year 5
Freedom from stage 3 SVD including stenosis and regurgitation determined by echocardiography
次要结局
未报告次要终点