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 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •1. Since this protocol stipulates that the study valve must be fully sutured in place (using standard valve suture placement technique) or abandoned at implant if the patient presents with fused or non-fused bicuspid valve or irregular annular geometry, any patient with fused or non-fused bicuspid valve or irregular annular geometry will be excluded if Investigator elects not to fully suture the valve in place. ;Intraoperative Exclusion Criteria
- •1. This patient presents with abnormal geometry of the coronary ostia, not seen by preoperative imaging, which presents a risk that the study device may occlude one or all ostia.
- •2. 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 not seen in preoperative imaging.
- •3. This patient has or requires treatment with a rigid annuloplasty ring in the mitral position at the time of the procedure.
- •4. This patient presents with active endocarditis not detected preoperatively.;Intraoperative Exclusion Criteria for Single Guiding Suture Technique
- •1. This patient presents with fused or non-fused bicuspid valve or irregular annular geometry not seen in preoperative imaging and Investigator elects not to fully suture the valve in place. Note: This protocol allows Investigator to implant the study device using standard valve suture placement in patients with fused or non-fused bicuspid valve or irregular annular geometry.
- •2. After debriding the annulus, the operating surgeon determines that this patient has residual calcification that would not provide optimal fit for the study device.
研究者
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