NCT05652062招募中不适用
An Exploratory Study to Evaluate the Prizvalve® System in Patients With Failing Bioprosthetic Valve
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Composite of all-cause mortality and valve-related reintervention
研究概览
简要总结
The primary purpose of this clinical trial is to evaluate the efficacy and safety of the transcatheter aortic valve system in the treatment of patients with failing bioprosthetic valve
详细描述
The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
- •Age≥18 years old who are not in pregnancy or lactation;
- •NYHA Function Class≥ II;
- •Patient who is anatomically suitable for the implantation of the Prizvalve® ;
- •According to heart team , patient is intermediate or above surgical risk or not suitable for redo open heart surgery of valve replacement due to other severe comorbidities ;
- •Heart team agrees valve implantation will likely benefit the patient;
- •Patient understands the purpose of the trial and volunteers to participate in, sign the informed consent form and is willing to accept relevant examinations and clinical follow-ups.
排除标准
- •Patients with other valvular diseases that require simultaneous intervention;
- •Patients with other heart diseases that require simultaneous intervention;
- •Estimated life expectancy < 12 months;
- •Failing valve has moderate and above paravalvular regurgitation;
- •Failing valve in unstable ore not structurally intact;
- •Increased risk of coronary artery obstruction by prosthetic leaflets of the failing valve;
- •Anatomical characteristics that would preclude transcatheter valve implantation;
- •Anatomical characteristics that would increase the risk of left ventricular outflow tract (LVOT) obstruction;
- •Patient with acute myocardial infarction within 30 days;
- •Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
- •Patient with hypertrophic cardiomyopathy with obstruction;
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- •Patients with active infective endocarditis or other active infections;
- •Patients with severe right ventricular dysfunction, or severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) < 20%;
- •Patients who cannot tolerate anticoagulant or antiplatelet therapy;
- •Patients with severe untreated coronary artery stenosis requiring revascularization;
- •Patients with cerebrovascular accident within 3 months, excluding transient ischemic attack;
- •Patients who refuse surgical treatment in emergency situations under any circumstances;
- •Patients who have severely disabled Alzheimer's disease and inability to take care of themselves;
- •Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
- •The investigator judged that patient with poor compliance and could not complete the study as required.
结局指标
主要结局
Composite of all-cause mortality and valve-related reintervention
时间窗: 1 year
次要结局
- Technical success(30 days)
- Procedural Success(30 days)
- Device success(30 days)
- All-cause mortality(30 days)
研究者
研究点 (1)
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