NCT06167213尚未招募不适用
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral
Edwards Lifesciences0 个研究点目标入组 125 人开始时间: 2027年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 主要终点
- Non-hierarchical composite of death and stroke at 1 year
研究概览
简要总结
This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.
详细描述
This is a prospective, single arm, multicenter, pivotal study.
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
- •Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- •Bioprosthetic surgical valve or native mitral annulus size suitable for SAPIEN X4 THV
- •NYHA functional class ≥ II
- •Heart Team agrees the subject is at high or greater surgical risk
- •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
- •Interatrial septum or left atrium not suitable for transcatheter transseptal access
- •Failing valve has mild or greater paravalvular regurgitation
- •Failing valve is unstable, rocking, or not structurally intact
- •Annuloplasty ring dehiscence
- •Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 10 mmHg at the end of the index procedure for implantation of the original valve
- •Annuloplasty ring type not favorable for THV implantation
- •Increased risk of THV embolization
- •Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction
- •Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant
- •Severe right ventricle (RV) dysfunction
- •Severe regurgitation or stenosis of any other valve
- •Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months
- •Left ventricular ejection fraction < 20%
- •Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- •Myocardial infarction within 30 days prior to the study procedure
- •Hypertrophic cardiomyopathy with subvalvular obstruction
- •Subjects with planned concomitant ablation for atrial fibrillation
- •Clinically significant coronary artery disease requiring revascularization
- •Any surgical or transcatheter procedure within 30 days prior to the study procedure. 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
- •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
- •Body mass index > 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
结局指标
主要结局
Non-hierarchical composite of death and stroke at 1 year
时间窗: 1 year
The number of patients that died or had a stroke
次要结局
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline(1 year)
- New York Heart Association (NYHA) functional class compared to baseline(1 year)
研究者
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