NCT02738853已完成不适用
The Medtronic TAVR 2.0 US Clinical Study
Medtronic Cardiovascular14 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2016年4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
- 93
- 试验地点
- 14
- 主要终点
- All-cause Mortality Rate
研究概览
简要总结
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement
详细描述
Prospective, single arm, multi-site study. Patients will be seen at pre and post procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis, defined as aortic valve area of <1.0 cm2 (or aortic valve area index of <0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR maximal aortic valve velocity >4.0 m/sec by resting echocardiogram
- •Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities
- •Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater
- •The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.
排除标准
- •Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
- •A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated:
- •aspirin or heparin (HIT/HITTS) and bivalirudin
- •ticlopidine and clopidogrel
- •nitinol (titanium or nickel)
- •contrast media
- •Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
- •End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min.
- •Ongoing sepsis, including active endocarditis
- •Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
- •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- •Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •Gastrointestinal (GI) bleeding that would preclude anticoagulation
- •Subject refuses a blood transfusion
- •Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
- •Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
- •Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
- •Currently participating in an investigational drug or another device study (excluding registries)
- •Evidence of an acute myocardial infarction ≤30 days before the study procedure
- •Need for emergency surgery for any reason
- •Liver failure (Child-Pugh class C)
- •Subject is pregnant or breast feeding
- •Pre existing prosthetic heart valve in any position
- •Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
- •Severe mitral regurgitation
- •Severe tricuspid regurgitation
- •Moderate or severe mitral stenosis
- •Hypertrophic obstructive cardiomyopathy
- •Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
- •Congenital bicuspid or unicuspid valve verified by echocardiography
- •Access vessel diameter <5.5 mm or <6.0 mm for patent left internal mammary artery (LIMA)
结局指标
主要结局
All-cause Mortality Rate
时间窗: 30 days
Stroke (Disabling) Rate
时间窗: 30 days
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
时间窗: 30 days
次要结局
- Hemodynamic Performance - Aortic Valve Area(30 days)
- Percentage of Participants With Coronary Artery Obstruction(30 days)
- Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure(30 days)
- Device Success Rate (VARC II)(24 hours to 7 days)
- Percentage of Participants With Life Threatening or Disabling Bleeding(30 days)
- Percentage of Participants With Major Vascular Complication(30 days)
- Hemodynamic Performance - Mean Gradient(30 days)
- Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:(30 days)
- Percentage of Patient With Acute Kidney Injury- Stage 2 or 3(30 days)
- Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace(30 days)
研究者
研究点 (14)
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