NL-OMON32374
撤回
不适用
ATS 3f Enable* Aortic Bioprosthesis pivotal study - ATS 3f Enable* Aortic Bioprosthesis
ATS Medical Inc.0 个研究点目标入组 30 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- ATS Medical Inc.
- 入组人数
- 30
- 状态
- 撤回
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Preoperative Inclusion Criteria
- •1\. This patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue).
- •2\. This patient is geographically stable and willing to return to the implant site for follow\-up visits.
- •3\. This patient has been adequately informed of risks and requirements and consents to his/her participation in the clinical study.
- •4\. If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7\) days prior to the study procedure.
排除标准
- •Preoperative Exclusion Criteria
- •1\. This patient requires replacement of two or more valves.
- •2\. This patient is \< 20 years of age.
- •3\. This 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 24 months.
- •4\. This patient is an intravenous drug and/or alcohol abuser.
- •5\. This patient presents with active endocarditis or other systemic infection.
- •6\. This patient has had previous valve replacement surgery, including previous implant and then explant of the ATS 3f Enable\* Aortic Bioprosthesis (Model 6000\) or placement of a rigid annuloplasty ring in the mitral position.
- •7\. This patient is participating in concomitant research studies of investigational products.
- •8\. This 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.
- •9\. This patient has chronic renal failure. ;Preoperative Exclusion Criterion for Single Guiding Suture Technique
结局指标
主要结局
未指定
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