Sorin Universal REgistry on Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2,758
- 试验地点
- 52
- 主要终点
- Composite rate of valve related major adverse events (MAEs)
研究概览
简要总结
Multi-center, International, Prospective, Non comparative, Non randomized, Open label.
5,000 patients to be enrolled approximately worldwide.
The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.
详细描述
SURE-AVR objective is to collect post market safety and performance data collected along the procedure and the relevant follow-up with Sorin Group aortic valve devices in accordance with the IFU to further evidence the safety and efficacy in a post-approval environment. All current and future Sorin Group aortic valve devices that have obtained CE-mark or other local regulatory and/or commercial approvals may be included in the registry. During the duration of the registry,other aortic valve replacement products or current devices might receive modifications and might become commercial available. This registry allows extensions for the inclusion of new products.
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry following the local applicable regulations.
The data collection shall be performed as per the local standard of care and without exposing the patient to any additional risk to the treatment (s)he would normally receive.
The registry is an open-ended project:
- Inclusions phase: open-ended
- Follow-up phase: annually throughout 5 years (7 and 10 years are optional).
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
- •All patients must provide written or oral informed consent to participate in the registry depending on the local regulations.
- •Patients having received a Sorin Group aortic valve device in accordance with the IFU
排除标准
- 未提供
结局指标
主要结局
Composite rate of valve related major adverse events (MAEs)
时间窗: At 5 years follow-up
To evaluate the composite rate of site reported valve related MAE defined as death, stroke and/or re-intervention (involving surgery or any other invasive therapy) at 5 years follow-up.
次要结局
- Echocardiographic evaluation(Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.)
- Composite rate of valve related MAE(4-year, and 7 and 10-year follow-up in selected centers only)
- Clinical success(30 days (average))
- Procedural timings(Intra-operative and at 30 days (average))
- Improvement of clinical status(Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.)
- Valve-related Serious Adverse Event (SAE)(Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.)
- MAE during the duration of the registry(Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.)