PERCEVAL S Valve Clinical Study for Chinese Registration
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- composite endpoint of thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days)
研究概览
简要总结
This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement and suitable to the PERCEVAL S valve.
The secondary objectives are to collect all relevant device and subject demographics, procedural and hospital discharge, short and long-term data, as described in the secondary endpoints section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject of age > 60 years.
- •Subject with aortic valve stenosis or steno-insufficiency.
- •Subject has signed the informed consent.
- •Subject in which preoperative evaluation is indicated for the need of native or prosthetic aortic valve replacement via open heart surgery
- •Subject is located in a geographic location that will enable the subject to return to the study site for follow-up examinations (i.e. geographically stable).
排除标准
- •Subject has preexisting valve prosthesis or annuloplasty rings in the mitral, pulmonic or tricuspid position.
- •Subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
- •Subject requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass graft (CABG).
- •Subject has active endocarditis.
- •Subject has active myocarditis
- •Subject has aneurysmal dilation or dissection of the ascending aortic wall.
- •Subject is drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
- •Subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the subject.
- •Subject with known hypersensitivity to nickel alloys.
- •Subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
- •Subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized for ≥30 days prior to the planned valve implant surgery.
- •Subject is known to be noncompliant or is unlikely to complete the study.
- •Subject with an aortic root enlargement, where the ratio between the diameter of the STJ and the annulus diameter, assessed by TEE, is > 1.
- •Or for other anatomical reasons that not suitable for PERCEVAL S per IB.
研究组 & 干预措施
Aortic Valve Replacement with Perceval S sutureless heart valve
Patient undergoing Aortic Valve Replacement with Perceval S sutureless heart valve
干预措施: Aortic Valve Replacement with Perceval S sutureless heart valve (Device)
结局指标
主要结局
composite endpoint of thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days)
时间窗: at one year
The primary endpoint includes thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (\>30 days) per CEC adjudication The number and percentage of subjects with free from thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death will be presented, along with individual component of the success.
次要结局
未报告次要终点