NCT01789567已完成不适用
Engager Direct Aortic Clinical Study: Medtronic Engager™ Transcatheter Aortic Valve Implantation System Via Direct Aortic Approach
Medtronic Cardiac Rhythm and Heart Failure12 个研究点 分布在 3 个国家目标入组 20 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- Acute Delivery System Success
研究概览
简要总结
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.
详细描述
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach in patients with symptomatic severe aortic valve stenosis at high or extreme risk for surgical aortic valve replacement for which treatment via direct aortic access is preferred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis as defined by Doppler echocardiography: aortic valve area ≤ 0.8 cm2 (or AVA index ≤ 0.5 cm2/m2), or mean gradient ≥ 40 mmHg, or max velocity ≥ 4m/s
- •NYHA Functional Class II or greater;
- •Logistic EuroSCORE I ≥ 20%, or comorbidity judged by the heart team to pose an absolute or relative contraindication for conventional aortic valve replacement;
- •Non-calcified ascending aortic site ≥ 50 mm from the aortic valve basal plane;
- •Age ≥ 18 years;
- •The patient has been informed of the nature of the study and has consented to participate, authorizing the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form"). Patient should understand the implications of participating in the study and should be legally competent to provide informed consent.
排除标准
- •Unicuspid or bicuspid aortic valve;
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
- •Left ventricular ejection fraction < 25%;
- •Left ventricular outflow obstruction, such as Hypertrophic Obstructive Cardiomyopathy and severe septal hypertrophy;
- •Mitral or tricuspid regurgitation greater than 2+ by angiography or moderate by echocardiography;
- •Patients with life expectancy less than 12 months due to an underlying non-cardiac co-morbid disease;
- •Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol or contrast medium that cannot be adequately controlled with pre-medication;
- •Sepsis or acute endocarditis;
- •Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy;
- •Renal insufficiency assessed by creatinine clearance < 20 ml/min and/or end-stage renal disease requiring chronic dialysis;
- •Active peptic ulcer or GI bleeding within 3 months from the planned index procedure;
- •Untreated clinically significant coronary artery disease requiring revascularization;
- •Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance;
- •Significant aortic disease, including abdominal and thoracic aortic aneurysm, defined as maximal luminal diameter of 5 cm or greater;
- •Need for emergency surgery, cardiac or non-cardiac;
- •History of myocardial infarction in the last 6 weeks;
- •History of TIA or CVA in the last 6 months;
- •Therapeutic invasive cardiac procedure, with the exception of BAV, performed within 30 days of the planned date of valve implantation, or 6 months in the case of drug-eluting stents;
- •Pre-existing prosthetic heart valve or prosthetic ring in any position;
- •Patent RIMA or pre-existing patent RIMA graft at direct aortic access site and/or trajectory;
- •Patient refuses a blood transfusion;
- •Pregnant or breastfeeding women;
- •Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.
结局指标
主要结局
Acute Delivery System Success
时间窗: Within 30 days of implant procedure
Acute delivery system success, defined as bioprosthesis deployed in anatomically correct position and freedom from delivery system related complications at the end of the procedure.
次要结局
未报告次要终点
研究者
研究点 (12)
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