Clinical Investigation of the Freedom SOLO Stentless Heart Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 702
- 试验地点
- 19
- 主要终点
- The complication and survival rates for the Freedom SOLO stentless valve.
研究概览
简要总结
This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
详细描述
Freedom SOLO study is a prospective, non-randomized, multicenter trial on the Freedom SOLOvalve implanted in patients requiring aortic valve replacement. The study was conducted at 18 centers in Europe.
The study was based on single sample hypothesis testing that allows comparison of observed morbid event rates to objective performance criteria (OPCs). Based on the guidelines established by the U.S. Food and Drug Administration (FDA), the minimum sample size for this study was 800 valve-years, which is the minimum amount of data needed to test against the OPC of 1.2 %/patient-year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is male or female 18 years old or older.
- •The patient is willing to sign the informed consent.
- •The patient which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
- •Any patient amenable to aortic valve replacement with biological prosthesis should be enrolled in the study, even in conjunction with valve repair, coronary artery bypass grafting and other procedures.
- •The patient is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
- •Patient will be available to the investigator(s) for postoperative follow-up beyond one year.
排除标准
- •The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
- •The patient requires a double or triple valve replacement (a valve repair is not considered an exclusion criterion).
- •The patient has a previously implanted SOLO valve, within the clinical study, that requires replacement.
- •The patient has active endocarditis.
- •The patient is or will be participating in a concomitant research study of an investigational product.
- •The patient is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent.
- •The patient 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 patient.
- •The patient is pregnant or lactating.
- •Patients with congenital bicuspid aortic valve.
- •Patients are known to be noncompliant or are unlikely to complete the study.
研究组 & 干预措施
Freedom SOLO stentless valve
Prospective data collection on the outcomes in patients treated with the CE Marked Freedom Solo Valve within the approved indication.
干预措施: Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis (Device)
结局指标
主要结局
The complication and survival rates for the Freedom SOLO stentless valve.
时间窗: up to 5 year
Safety of the Freedom SOLO was evaluated based on the following adverse events related to cardiac valve replacement: valve thrombosis, thromboembolism, bleeding, anticoagulant-related bleeding, paravalvular leak, endocarditis, clinically significant hemolysis, nonstructural dysfunction, structural valve deterioration, reoperation, explant, and death.
The complication and survival rates for the Freedom SOLO stentless valve.
时间窗: up to 1 year
Safety of the Freedom SOLO was evaluated based on the following adverse events related to cardiac valve replacement: valve thrombosis, thromboembolism, bleeding, anticoagulant-related bleeding, paravalvular leak, endocarditis, clinically significant hemolysis, nonstructural dysfunction, structural valve deterioration, reoperation, explant, and death.
次要结局
- Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients(up to 5 year)
- Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.(up to 5 year)
- Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography(up to 5 year)
- Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition.(up to 5 year)
- Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2).(up to 5 year)
- Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition.(up to 5 year)
- Preoperative and postoperative NYHA functional classifications(Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter)