NCT05172960招募中不适用
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
Edwards Lifesciences127 个研究点 分布在 3 个国家目标入组 1,234 人开始时间: 2022年6月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,234
- 试验地点
- 127
- 主要终点
- Non-hierarchical composite of death and stroke
研究概览
简要总结
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
详细描述
This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Severe, calcific AS
- •Native aortic annulus size suitable for SAPIEN X4 THV
- •NYHA functional class ≥ II
- •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
- •Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- •Aortic valve is unicuspid, bicuspid or non-calcified
- •Pre-existing mechanical or bioprosthetic valve in any position
- •Severe aortic regurgitation (> 3+)
- •Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis
- •Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
- •Left ventricular ejection fraction < 20%
- •Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- •Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation
- •Increased risk of coronary artery obstruction after THV implantation
- •Myocardial infarction within 30 days prior to the study procedure
- •Hypertrophic cardiomyopathy with subvalvular obstruction
- •Subjects with planned concomitant ablation for atrial fibrillation
- •Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
- •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.
- •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)
- •Endocarditis within 180 days prior to the study procedure
- •Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
- •Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
- •Renal insufficiency and/or renal replacement therapy
- •Leukopenia, anemia, thrombocytopenia
- •Inability to tolerate or condition precluding treatment with antithrombotic therapy
- •Hypercoagulable state or other condition that increases risk of thrombosis
- •Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
- •Subject refuses blood products
- •BMI > 50 kg/m2
- •Estimated life expectancy < 24 months
- •Female who is pregnant or lactating
- •Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- •Participating in another investigational drug or device study that has not reached its primary endpoint
- •Subject considered to be part of a vulnerable population
研究组 & 干预措施
TAVR - X4S Registry
Experimental
Subjects will undergo transcatheter aortic valve replacement (TAVR)
干预措施: SAPIEN X4S (Device)
TAVR - Main Cohort
Experimental
Subjects will undergo transcatheter aortic valve replacement (TAVR)
干预措施: SAPIEN X4 THV (Device)
TAVR - Bicuspid Registry
Experimental
Subjects with bicuspid aortic valve morphology will undergo TAVR
干预措施: SAPIEN X4 THV (Device)
结局指标
主要结局
Non-hierarchical composite of death and stroke
时间窗: 1 year
The number of patients that died or had a stroke
次要结局
- New permanent pacemaker implantation(30 days)
- Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baseline(1 year)
- Paravalvular leak(30 days)
研究者
研究点 (127)
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