DurAVR™ THV System: European Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- All-cause mortality or disabling stroke
研究概览
简要总结
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.
详细描述
The DurAVR™ THV System is a novel balloon-expandable single-piece transcatheter aortic valve.
The study will enroll up to 40 subjects with severe, symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves, with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.
Subjects will be consented for follow-up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- •Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
- •Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
- •Eligible for transfemoral 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 mitral or tricuspid valve
- •Unicuspid, bicuspid or non-calcified aortic valve
- •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
- •Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
- •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
- •Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •End-stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min
- •GI bleeding within the past 3 months
- •Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
- •Life expectancy < 12 months due to associated non-cardiac co-morbid conditions
研究组 & 干预措施
Severe Aortic Stenosis (sAS) Cohort
Subjects with symptomatic severe native aortic stenosis with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.
干预措施: DurAVR™ THV System (Device)
Failed Surgical Aortic Bioprosthetic Valve (FAV) Cohort
Subjects with severe degeneration of surgically implanted aortic bioprosthetic valves with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.
干预措施: DurAVR™ THV System (Device)
结局指标
主要结局
All-cause mortality or disabling stroke
时间窗: 30 Days
Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines
次要结局
- Disabling stroke(30 Days)
- All-cause mortality(30 Days)
- Life-threatening bleeding(30 Days)
- New permanent pacemaker due to procedure related conduction abnormalities(30 Days)
- Surgery or intervention related to the device, including aortic valve reintervention(30 Days)
- Major vascular, access-related, or cardiac structural complication(30 Days)
- Moderate or severe aortic regurgitation(30 Days)
- Acute kidney injury stage 3 or 4(30 Days)