ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 11
- 主要终点
- Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000
研究概览
简要总结
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.
详细描述
A multi-center non-randomized trial designed to obtain 606 patient years. Each enrolled patient will be followed for a minimum of six (6) years. Preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is </= 70 years of age and requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction. (The three remaining valves must be of native tissue).
- •Patient is sufficiently ill to warrant replacement of his/her diseased natural or prosthetic valve (excluding the ATS 3f Aortic Bioprosthesis, Model 1000 bioprosthesis), based on standard cardiovascular diagnostic workups.
- •Patient is in satisfactory condition, based on the physical exam and Investigator's experience, to be an average or better operative risk, (i.e., likely to survive three years postoperatively).
- •Patient is geographically stable and willing to return to the implant center for follow-up visits.
- •Patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
排除标准
- •Patient is older than seventy (70) years of age.
- •Patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 3 years.
- •Patient is an intravenous drug and/or alcohol abuser.
- •Female patient is pregnant (urine HCG test result positive), or lactating.
- •Patient presents with active endocarditis.
- •Patient presents with congenital bicuspid aortic anatomy.
- •This patient presents with abnormal aortic root geometry.
- •Patient has chronic renal failure or is on renal dialysis.
- •Patient has a previously implanted prosthetic valve that is not being replaced by a study valve.
- •Patient requires mitral, tricuspid or pulmonic valve replacement.
- •Patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.
- •Patient is participating in concomitant research studies of investigational products.
- •Patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
结局指标
主要结局
Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000
时间窗: Six Years
Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.
次要结局
- Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.(Six Years)