Regent China Post-Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Primary Safety Endpoint: The Freedom From Valve-related Mortality
研究概览
简要总结
Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.
详细描述
The purpose of the RC-PMCF study is to meet the post-market clinical followup (PMCF) requirements of the National Medical Products Administration (NMPA). The primary objective of this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population. This is a prospective, observational, multi-center study of subjects clinically indicated for implantation of an Abbott Medical's Regent Valve.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patient is eligible to be implanted with Regent to replace a native or prosthetic aortic valve per Regent's IFU.
- •Subject will be >18 years of age at time of being consented.
- •Subject, provides written informed consent prior to any clinical investigation-specific procedure.
排除标准
- •Subject is unable to tolerate anticoagulation therapy.
- •Subject has active endocarditis.
- •Subject is currently participating in another clinical investigation which may interfere with the effectiveness of anticoagulation therapy.
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Women of child-bearing potential must have a documented negative pregnancy test within one week prior to enrollment.
- •Subject has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
- •Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
- •Subject's life expectancy is less than 1 year in the opinion of the Investigator.
结局指标
主要结局
Primary Safety Endpoint: The Freedom From Valve-related Mortality
时间窗: At one year
Valve-related mortality is any death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death. Deaths caused by heart failure in patients with advanced myocardial disease and satisfactorily functioning cardiac valves are not counted. Specific causes of valve-related deaths should be reported.
Primary Performance Endpoint: The Freedom From Valve-related Reoperation
时间窗: At one year
Valve-related reoperation includes any reintervention that is a surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces the previously implanted prosthesis or repaired valve.
次要结局
未报告次要终点