ACTRN12624000100594招募中Unknown
Prospective, single arm, multicentre, feasibility study to demonstrate the safety and functionality of the Edwards 12F Sheath Introducer Set in conjunction with the SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS) (Protocol number: 2023-06)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Severe, calcific AS
- •2.Native aortic annulus size suitable for SAPIEN X4 THV
- •3.NYHA functional class greater than or equal to II
- •4.The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
排除标准
- •1.Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- •2.Aortic valve is unicuspid, non-calcified, or aortic valve is bicuspid with aneurysmal ascending aorta greater than 4.5 cm and/or severe raphe/leaflet calcification
- •3.Pre-existing mechanical or bioprosthetic valve in any position
- •4.Severe aortic regurgitation (greater than 3plus)
- •5.Severe mitral regurgitation (greater than 3olus) or greater than or equal to moderate mitral stenosis
- •6.Need for mitral, tricuspid, or pulmonic valve intervention within the next 12 months
- •7.Left ventricular ejection fraction less than 20%
- •8.Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- •9.Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak (PVL) after THV implantation
- •10.Increased risk of coronary artery obstruction after THV implantation
- •11.Myocardial infarction within 30 days prior to the study procedure
- •12.Hypertrophic cardiomyopathy with subvalvular obstruction
- •13.Subjects with planned concomitant ablation for atrial fibrillation
- •14.Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
- •15.Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
- •16.Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)
- •17.Endocarditis within 180 days prior to the study procedure
- •18.Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
- •19.Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
- •20.Renal insufficiency and/or renal replacement therapy
- •21.Leukopenia, anaemia, thrombocytopenia
- •22.Inability to tolerate or condition precluding treatment with antithrombotic therapy
- •23.Hypercoagulable state or other condition that increases risk of thrombosis
- •24.Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
- •25.Subject refuses blood products
- •26.BMI greater than 50 kg/m2
- •27.Estimated life expectancy less than 24 months
- •28.Female who is pregnant or lactating
- •29.Active SARS-CoV-2 infection
- •30.Participating in another investigational drug or device study that has not reached its primary endpoint
- •31.Subject considered to be part of a vulnerable population
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