RBR-744myhk招募中未知
Transfemoral Implant of the Inovare® Transcatheter Valve - Clinical trial for safety and effectiveness erification
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP0 个研究点开始时间: 2023年2月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 90Y（—）
入选标准
- •Patients with significant calcified degenerative native aortic valve stenosis; Multidisciplinary evaluation by the Heart Team that concludes that the patient has a high surgical risk for aortic valve replacement, or presence of porcelain aorta or hostile chest, as well as global clinical condition and comorbidities not fully addressed by the STS risk score, or extreme fragility, or considerable chance of clinical benefit from the transcatheter procedure; Symptoms of heart failure in NYHA functional class equal to or greater than II II; Aortic valve ring with an average diameter between 17,3 and 28,6 mm, documented by imaging method, suitable for positioning and accommodating the Inovare® prosthesis; Coronary ostia height greater than 10 mm or presence of coronary graft that prevents the occurrence of acute myocardial ischemia due to coronary occlusion after the valve is released; Arterial femoral access route considered adequate for the progression of the vascular introducer and prosthesis-balloon system; Signed Free and Informed Consent Form.
排除标准
- •Clinicos: Hemodynamic instability requiring vasoactive drugs or circulatory support; procedure with a clinical need to be carried out in an emergency or time of urgency (not elective); a left-side ventrical fracture that is less than 30%; Diabetic renal insufficiency; severe renal insufficiency with persistently elevated levels of creatinine; clinical or biological signs of infection with widespread effects; Endocardite at intervals no greater than 12 months; a coronary disease requiring elective revascularization during or after the valve procedure; evidence of myocardial infarction within a month or less; cerebral vascular accident or recent transient ischaemic attack (within the last six months); sensitivity to or contraindication to the administration of heparin, ticlopidine, clopidogrel, or radiopaco contrast agent; Anemia, hyperthyroidism, or plaquetopenia; a critical need for anticoagulation due to other causes; active peptic disease, gastrointestinal bleeding within three months or previously diagnosed hemorrhagic days; Expectation of life of less than 12 months due to non-cardiac disease or other disorders.
- •Anatômicos/morfológicos: Diameter of anel valve greater than or equal to 28,7 mm, or less than or equal to 17,2 mm; ilaco-femoral access route with tortuosity, severe calcification, or reduced luminal diameter that prevents the safe advancement of the introducer arterial and prate system; detection of the presence of stable and significant atheromas in the ascending aorta and/or aortic arch using imaging methods; miocardiopathy with obstructed or severe obstruction of the left ventricle's exit pathway without possibility of balloon dilatation; Procedure to previously valve the aorta or the mitral (by surgery or by catheter, excluding aorta valvoplastia by balo); moderate or accentuated aortic, mitral, or tricuspid insufficiency; native valve not calcified; Evidence of mass intracardiac bleeding.
研究者
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