Perceval S Valve Clinical Trial for Extended CE Mark
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 658
- 试验地点
- 51
- 主要终点
- Evaluation of the safety: incidence of mortality
研究概览
简要总结
The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
详细描述
Primary Endpoints
The primary endpoint of the clinical investigation is the evaluation of the safety and effectiveness of the Perceval S valve at 12 months after implant.
The safety of Perceval valve will be assessed in terms of percentage incidence of mortality and morbidity at 12 months after implant.
The effectiveness of the Perceval s valve will be assessed in terms of:
- Improvement of clinical status by mean of New York Heart Association (NYHA) functional class at 12 months after implant
- Haemodynamic performance through echocardiography parameters as mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation at 12 months after implant
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of age > 65 years;
- •Subjects with aortic valve stenosis or steno-insufficiency;
- •Subjects in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement with a biological prosthesis;
- •Subjects willing to sign the informed consent;
- •Subjects willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the Study
排除标准
- •Subjects involved in any other clinical study for drugs or devices;
- •Subjects with a previously implanted Perceval S prosthesis, within the clinical study, that requires replacement
- •Subjects with previous implantation of valve prostheses or annuloplasty ring not being replaced by the study valve
- •Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass
- •Subjects who require double or multiple valve replacement or repair in whom the mitral, tricuspid, or pulmonic valve would be replaced with a non-Perceval S valve or repaired
- •Subjects with aneurysmal dilation or dissection of the ascending aortic wall
- •Subjects needing non elective intervention
- •Subjects with active endocarditis
- •Subjects with active myocarditis
- •Subjects with congenital bicuspid aortic valve
- •Subjects with aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is > 1.3 (see Attachment 1 for reference)
- •Subjects with aortic root height (measured from aortic annulus to sino-tubular junction) ≥ 21 mm for size 21, ≥ 22.5 mm for size 23 and ≥ 24 mm for size 25, and ≥ 25 mm for size XL/27
- •Subjects with myocardial infarction < 90 days before the planned valve implant surgery
- •Subjects with known hypersensitivity to nickel alloys
- •The subject has a documented history of substance (drug or alcohol) abuse
- •The subject is a prison inmate, institutionalized, or is unable to give informed consent;
- •The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy shorter than 1 year, or the implant of the device produces an unacceptable increased risk to the patient
- •The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
- •The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥ 30 days prior to the planned valve implant surgery
研究组 & 干预措施
Perceval S Valve Prosthesis
Patients who underwent replacement of diseased or malfunctioning native aortic valve with the Perceval S Valve prosthesis
干预措施: Perceval S Valve Prosthesis (Device)
结局指标
主要结局
Evaluation of the safety: incidence of mortality
时间窗: 12 months after OP
Incidence of mortality
Evaluation of the safety: Incidence of morbidity
时间窗: 12 months after OP
Incidence of morbidity Mortality and morbidity, adverse event categories: valvular thrombosis, thromboembolism, hemorrhage, paravalvular leak, endocarditis, hemolysis, SVD, non structural dysfunction, reoperation, explant, death, device dislodgement and device migration
Evaluation of NYHA functional class
时间窗: 12 months after OP
Change of NYHA functional class
Evaluation of haemodynamic performance: Cardiac Index
时间窗: 12 months after OP
Change of Cardiac Index (l/min/m2)
Evaluation of haemodynamic performance: mean and peak gradients
时间窗: 12 months after OP
Change of aortic mean gradient and peak gradient (mmHg)
Evaluation of haemodynamic performance: Effective Orifice Area (EOA) and Effective Orifice Area indexed (EOAI)
时间窗: 12 months after OP
Change of EOA (cm2) and EOAI (cm2/m2) PI, cardiac output, cardiac index and degree of regurgitation
Evaluation of haemodynamic performance: Cardiac Output
时间窗: 12 months after OP
Change of Cardiac Output (l/min)
Evaluation of haemodynamic performance: incidence and degree of regurgitation
时间窗: 12 months after OP
Change of incidence (%) and degree of regurgitation (none, trace, mild, moderate, severe)
次要结局
- Evaluation of the safety: Incidence of morbidity(up to 10 years)
- Evaluation of haemodynamic performance(up to 10 years)
- Evaluation of the safety: incidence of mortality(3-6 months)
- Evaluation of NYHA functional class(up to 10 years)
- Evaluation of the safety: Incidence of mortality(up to 10 years)