NL-OMON40520已完成2 期
REPRISE II: Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Perfomance - REPRISE II
Boston Scientific International0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- •IC1. Subject is >=70 years of age
- •IC2. Subject has documented calcific native aortic valve stenosis with an initial aortic valve area (AVA) of <1.0 cm2 (or AVA index of <0.6 cm2/m2) and either a mean pressure gradient >40 mm Hg or a jet velocity >4 m/s, as measured by echocardiography
- •IC3. Subject has a documented aortic annulus size between >=20 and <=27 mm based on pre-procedure diagnostic imaging
- •IC4. Symptomatic aortic valve stenosis with NYHA Functional Class >= II
- •IC5. Subject is considered high risk for surgical valve replacement based on at least one of the following:
- •a. Society of Thoracic Surgeons (STS) score >=8%, AND/OR
- •b. Agreement by the heart team (which must include an in-person evaluation by an experienced cardiac surgeon) that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement
- •IC6. Heart team (which must include an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
- •IC7. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
- •IC8. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
排除标准
- •EC1. Subject has a congenital unicuspid or bicuspid aortic valve.
- •EC2. Subject with an acute myocardial infarction within 30 days of the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation >= twice normal in the presence of CK-MB elevation and/or troponin elevation).
- •EC3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
- •EC4. Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µmol/L.
- •EC5. Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
- •EC6. Subject has >=3+ mitral regurgitation, >=3+ aortic regurgitation or >=3+ tricuspid regurgitation (i.e., subject cannot have more than moderate mitral, aortic or tricuspid regurgitation).
- •EC7. Subject has a need for emergency surgery for any reason.
- •EC8. Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
- •EC9. Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
- •EC10. Subject has Hgb <9 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
- •EC24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation.
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