NCT05712161进行中（未招募）不适用
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Technical success
研究概览
简要总结
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
详细描述
The primary objective is to assess the acute and long-term safety and feasibility of the DurAVR™ device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement as assessed by the Heart Team at the enrolling institutions.
This is a prospective, non-randomized, single-arm, multi-center Study. Subjects will be consented for follow-up to 10 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
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible for entry in this study if ALL the following conditions are met:
- •Symptomatic, severe native aortic stenosis in subjects 65 years or older
- •Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
- •Eligible for transfemoral delivery of the DurAVR™ THV
- •Anatomy appropriate to accommodate safe placement of DurAVR™ THV (Preprocedural measurements by TTE and CT required: aortic annulus diameter 21-23 mm by CT)
- •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
- •Subjects are eligible for entry in this study if NONE of the following conditions are met:
- •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
- •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 < 1000 mm3), 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 (Duke Criteria) [49]
- •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 is contraindicated for MDCT or MRI Scans.
- •Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).
研究组 & 干预措施
DurAVR™ THV System
Experimental
TAVR procedure
干预措施: DurAVRTM THV System (Device)
结局指标
主要结局
Technical success
时间窗: Immediate post procedure
Freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device.
All-cause mortality or disabling stroke
时间窗: 30days
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
- Major vascular, access-related, or cardiac structural complication(30days)
- All-cause mortality(30days)
- VARC-3 Type 2-4 bleeding(30days)
- Acute Kidney Injury stage 3 or 4(30days)
- Moderate or severe aortic regurgitation(30days)
- New permanent pacemaker due to procedure related conduction abnormalities(30days)
- Disabling stroke(30days)
- Surgery or intervention related to the device, including aortic valve reintervention.(30days)
研究者
研究点 (6)
Loading locations...
相似试验
进行中（未招募）
不适用
DurAVR™ THV System: EMBARK StudySymptomatic Aortic StenosisSevere Aortic Valve StenosisAortic Valve CalcificationNCT05182307Anteris Technologies Ltd.150
进行中（未招募）
不适用
DurAVR™ THV EU-EFSAortic Valve FailureSymptomatic Aortic StenosisSevere Aortic Valve StenosisAortic Valve CalcificationAortic Valve DiseaseNCT06510855Anteris Technologies Ltd.15
已完成
3 期
Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OABOveractive BladderNCT02485067SK Chemicals Co., Ltd.384
Unknown
4 期
Treatment of Primary CNS LymphomaPrimary CNS Lymphoma (PCNSL)NCT01960192Mingzhi Zhang50
已完成
不适用
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter StudyPulmonary Valve StenosisCongenital Heart DefectPulmonary Valve Insufficiency, CongenitalNCT03110861Taewoong Medical Co., Ltd.15