Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 255
- 试验地点
- 13
- 主要终点
- Subject's Occurrence Rate of Study Valve Related Death
研究概览
简要总结
The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.
详细描述
The trial is a multi-center, prospective, single-arm study that will enroll up to 250 subjects. The study is being divided into 2 stages: Stage 1 is enrollment and 5 years of follow-up after implantation. Stage 2 is additional follow-up through 10 years upon authority's feedback if needed.
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
- •Subject is 18 years or older
- •Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU
- •Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement
- •Provide signed informed consent prior to the study participation
排除标准
- •Valve implantation is contraindicated per the IFU
- •Requires planned multiple valve replacement/ repair
- •Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery
- •Estimated Life expectancy< 12 months
- •Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
结局指标
主要结局
Subject's Occurrence Rate of Study Valve Related Death
时间窗: 5 Years
The primary safety endpoint is the percentage of study valve related death which includes 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.
Subject's Occurrence Rate of Thromboembolic Events
时间窗: 5 Years
The primary safety endpoint is the rate of thromboembolic events which is an embolic event that occurs in absence of infection (endocarditis) starting from anesthesia time. Embolism may be manifested by a neurologic event (Stroke or Transient Ischemic Attack) or a non-cerebral embolic event.
Subject's Occurrence Rate of Re-operation on the Study Valve
时间窗: 5 Years
The primary safety endpoint is the reoperation rate on the study valve which is any operation that repairs, alters, or replaces the study valve, which occurs after the completion of the procedure and the transfer out of the procedure room.
Subject's Occurrence Rate of Structural Valve Deterioration
时间窗: 5 Years
The primary safety endpoint is the percentage of Structural Valve Deterioration which includes dysfunction or deterioration involving the operated valve (exclusive of infection or thrombosis), as determined by re-operation, autopsy, or clinical investigation.
Subject's Occurrence Rate of Major Bleeding
时间窗: 5 Years
The primary safety endpoint is the rate of major bleeding which is any episode of major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. Vision loss) or necessitates transfusion of 3 or more units of PRBC, pericardiocentesis, or exploration/reoperation for bleeding.
Subject's Occurrence Rate of Transient Ischemic Attack
时间窗: 5 Years
The primary safety endpoint is the rate of transient ischemic attacks which is characterized by fully reversible symptoms of short duration.
Subject's Occurrence Rate of Non-Cerebral Thromboembolism
时间窗: 5 Years
The primary safety endpoint is the rate of non-cerebral thromboembolism which is an embolus documented operatively, at autopsy, or clinically that produces signs or symptoms attributable to complete or partial obstruction of a peripheral artery (does not include deep vein thrombosis).
Subject's Occurrence Rate of Stroke
时间窗: 5 Years
The primary safety endpoint is the rate of strokes which is a prolonged (\>72 hours) or permanent neurologic deficit that is usually associated with abnormal results of magnetic resonance imaging or computed tomographic scans.
次要结局
- Subject's Average Mean Gradient at 5 Years(5 Years)
- Subject's Average Peak Gradient at 5 Years(5 Years)
- Subject's Average Effective Orifice Area at 5 Years(5 Years)
- Subject's Average Effective Orifice Area Index at 5 Years(5 Years)
- Amount of Aortic Central Regurgitation in Subjects at 5 Years(5 Years)
- Amount of Aortic Paravalvular Regurgitation in Subjects at 5 Years(5 Years)