Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: First In Human Study (EMBARK Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
详细描述
The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve.
The study will enroll up to 150 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic, severe aortic stenosis
- •Eligible for delivery of the DurAVR™ THV
- •Anatomy appropriate to accommodate safe placement of DurAVR™ THV
- •Understands the study requirements and the treatment procedures and provides written informed consent.
- •Subject agrees to complete all required scheduled follow-up visits.
排除标准
- •Anatomy precluding safe placement of DurAVR™ THV
- •Pre-existing prosthetic heart valve in any position
- •Unicuspid or bicuspid aortic valve
- •Severe aortic regurgitation
- •Severe mitral or severe tricuspid regurgitation requiring intervention
- •Moderate to severe mitral stenosis
- •Hypertrophic obstructive cardiomyopathy
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
- •Severe basal septal hypertrophy with outflow gradient Clinical
- •Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
- •Determined inoperable/ineligible for surgery by the Heart Team
- •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
- •Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- •Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
- •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- •Need for emergency surgery for any reason
- •Ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 30% as measured by resting echocardiogram
- •Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •Symptomatic carotid or vertebral artery disease
- •End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min
- •GI bleeding within the past 3 months
- •A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, nitinol (titanium or nickel), ticlopidine and clopidogrel, contrast media
- •Ongoing sepsis, including active endocarditis
- •Subject refuses a blood transfusion
- •Life expectancy < 12 months due to associated non-cardiac co-morbid conditions
- •Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
- •Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
- •Currently participating in an investigational drug or another investigational device trial
- •Subject belongs to a vulnerable population.
研究组 & 干预措施
Treatment
DurAVR™ THV System
干预措施: DurAVR™ THV System (Device)
结局指标
主要结局
All-cause mortality
时间窗: 1 year
All-cause mortality
Stroke
时间窗: 1 year
Disabling Stroke (VARC-3 Guidelines)
Myocardial infarction
时间窗: 1 year
Myocardial infarction
Life-threatening bleeding
时间窗: 1 year
Life-threatening bleeding (VARC-3 Guidelines)
DurAVR™ prosthetic heart valve implant
时间窗: Immediate post procedure
Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location
Hemodynamic performance
时间窗: Immediate post procedure
Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI)
次要结局
未报告次要终点