Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Safety performance
研究概览
简要总结
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
详细描述
A multicenter, observational, retrospective, single-arm study. This study will include patients who underwent valve replacement (native or bioprosthetic) of the aortic or mitral valves using the VIVERE Bovine Pericardial Bioprosthetic Valve, between 2017 and 2022. Data will be collected up to 3 years post-procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •All patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the native valve or bioprosthesis in the aortic or mitral position, in accordance with the Instructions for Use (IFU).
- •Patients aged > 18 years.
排除标准
- •Patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the tricuspid or pulmonary valve.
- •Contraindications specified in the IFUs.
结局指标
主要结局
Safety performance
时间窗: Hospital discharge or within 30 days of the procedure, whichever occurs first.
Procedure- or device-related mortality
Efficacy outcome
时间窗: 3 years post-implant
Percentage of patients in NYHA (New York Heart Association functional classification) Class I or II at 3 years post-implant.
次要结局
- Clinical success(Hospital discharge)
- Composite serious valve-related adverse events (non-linearized)(From immediately after the intervention until study completion, with an average follow-up of 3 years)
- Hemodynamic Performance(From immediately after the intervention until study completion, with an average follow-up of 3 years)
- Structural Valve Deterioration(30 days, 1 year, 2 years, and 3 years)
- Serious Adverse Events (linearized rates)(30 days, 1 year, 2 years, and 3 years)
- All-Cause Mortality(3 years post-valve implantation)