NCT07122050尚未招募不适用
Safety and Effectiveness of Prizvalve Transcatheter Aortic Valve in Patients With Failing Bioprosthetic Valves
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年8月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the Prizvalve transcatheter aortic valve in subjects who are at high or greater risk with failing bioprosthetic valves.
详细描述
Prospective, single arm, multicenter 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
- 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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation:
- •Age≥18 years old;
- •Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
- •NYHA Function Class≥ II;
- •Patient who is anatomically suitable for the implantation of the Prizvalve®;
- •According to heart team , patient is at high or greater surgical risk or not suitable for redo open heart surgery of valve replacement;
- •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
- •Moderate or greater paravalvular regurgitation of the degenerated bioprosthetic valve；
- •Degenerated valve that cannot be securely fixed within the native annulus or exhibits structural incompleteness；
- •Anatomical features deemed unsuitable for transcatheter implantation.
- •Anatomical features that significantly increase the risk of left ventricular outflow tract (LVOT) obstruction；
- •Acute myocardial infarction within 30 days prior to enrollment；
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation；
- •Active infective endocarditis or any other active infection；
- •Severe right ventricular dysfunction or severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20 %；
- •Inability to tolerate anticoagulant or antiplatelet therapy；
- •Cerebrovascular accident within 3 months prior to enrollment, excluding transient ischemic attack；
- •Refusal to undergo emergency cardiac surgery under any circumstances；
- •Participation in another drug or device clinical trial that has not yet reached its primary endpoint as of the time of enrollment；
- •Investigator-assessed poor compliance that would preclude adherence to protocol requirements；
结局指标
主要结局
All-cause mortality
时间窗: At 30 days
The primary end point is the 30 days all-cause mortality
次要结局
- Device success(immediate post-surgical)
- Procedural success(immediate post-surgical)
- All-cause mortality(At 6 months, 1 year)
- The incidence of rehospitalization(At 30 days, 6 months, 1 year)
- The incidence of myocardial infarction(At 30 days, 6 months, 1 year)
- The incidence of stroke(At 30 days, 6 months, 1 year)
- The incidence of bleeding(At 30 days, 6 months, 1 year)
- The incidence of acute kidney injury(At 30 days, 6 months, 1 year)
- The incidence of permanent pacemaker implantation(At 30 days, 6 months, 1 year)
- The incidence of vascular and access-related complications(At 30 days, 6 months, 1 year)
- The incidence of procedure-related complications(At 30 days, 6 months, 1 year)
- The incidence of valve dysfunction(At 30 days, 6 months, 1 year)
- The incidence of NYHA functional class improvement(At 30 days, 6 months, 1 year)
- The incidence of quality-of-life improvement(At 30 days, 6 months, 1 year)
- The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)(At 30 days, 6 months, 1 year)
研究者
研究点 (1)
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