NCT05409378撤回不适用
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- HLT Inc.
- 试验地点
- 6
- 主要终点
- Mortality at 30 days
研究概览
简要总结
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
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
- •Subject has evidence of severe aortic regurgitation as assessed by the independent echo core lab according to an integrative multiparametric based on ASE (American Society of Echocardiography) guidelines considering qualitative and quantitative measures.
- •Symptoms due to severe aortic regurgitation with a NYHA Functional Classification of II or greater
- •Documented aortic valve annular diameter ≥ 21 and ≤ 26 mm (associated perimeter range is 66.0 - 81.7 mm or associated area range of 346 - 531 mm^2) measured by the MSCT Core Lab assessment of pre-procedure imaging
- •Documented heart team agreement of high risk for surgical aortic valve replacement (SAVR)
- •Geographically available, willing to comply with follow-up and able to provide written informed consent.
排除标准
- •Congenital, unicuspid or bicuspid aortic valve which could compromise procedural success
- •Severe mitral or tricuspid valve regurgitation
- •Moderate to severe mitral stenosis
- •Myocardial infarction within the past 30 days*
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- •Left Ventricular Ejection Fraction (LVEF) < 35%
- •Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
- •Hemodynamic instability requiring inotropic drug therapy within the past 30 days
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure, except for PCI which is performed within 7 days prior to the index procedure*
- •Presence of significant aortic disease such as atheroma, thrombus, dissection (> 50 mm in diameter or which could be considered high risk for dissection) or aneurysm which precludes safe implant delivery
- •Blood dyscrasias defined as leukopenia (White blood cell count < 1,000 cell/mm^3), anemia (hemoglobin < 9.0 g/dL), thrombocytopenia (platelet count < 50,000 cells/mm^3), history of bleeding diathesis or coagulopathy
- •Patient ineligible for or refuses blood transfusions
- •Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity) that would preclude passage of 18F catheters from the femoral arterial access to the aorta by the MSCT Core Lab assessment of pre-procedure imaging
- •Active peptic ulcer or gastrointestinal bleeding requiring hospitalization or transfusion within the past 90 days, that would not allow treatment with the protocol antiplatelet regimen post implant *
- •Symptoms of carotid or vertebral artery disease (e.g. stroke or transient ischemic attack) within past 6 months, or treatment of carotid stenosis within past two months*
- •At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for eligibility
结局指标
主要结局
Mortality at 30 days
时间窗: 30-Days
The primary safety endpoint is all-cause mortality at 30 days
次要结局
- Adverse Events(Up to 5 years following enrollment)
- Post-procedural Valve Performance - Aortic Valve Gradient assessed via Echo(Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months)
- Device Success- A composite endpoint per VARC-3, defined as meeting the following:(30 Days)
- Post-procedural Valve Performance- Aortic Regurgitation (AR) assessed via Echo(Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months)
- Technical Success - A composite endpoint per VARC-3, defined as meeting the following:(Immediately after procedure)
- Post-procedural Valve Performance - EOA assessed via Echo(Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months)
研究者
研究点 (6)
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