NL-OMON34868已完成不适用
Perceval S valve clinical trial for extended CE-mark - CAVALIER study
Sorin Biomedica CRM SR0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
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
- •Subjects of age 65 (or older) 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;
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;
- •Subjects with aneurysmal dilation or dissection of the ascending aortic wall;
- •Subjects with active endocarditis, myocarditis;
- •Subjects with congenital bicuspid aortic valve;
- •Subjects with myocardial infarction < 90 days before the planned valve implant surgery;
- •Subjects with known hypersensitivity to nickel alloys.
研究者
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