Anchord Mitral Chordal Repair System for Patients With Degenerative Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 主要终点
- Incidence of device or procedure related major adverse events [Safety]
研究概览
简要总结
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal Repair System in patients with degenerative mitral regurgitation. The main question[s] it aims to answer are to assess the safety of procedure, the reduction in mitral regurgitation severity and changes in hemodynamic and symptomatic status.
Participants will be implanted with the Anchord device.
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
- •Severe symptomatic degenerative mitral regurgitation (grade 3+)
- •High surgical risk for open-heart mitral valve repair or replacement
- •Suitable anatomy for transcatheter chordal repair as determined by the treating physician
- •Ability to undergo required echocardiographic and fluoroscopic imaging
- •Ability to provide informed consent
排除标准
- •Active endocarditis or systemic infection
- •Severe left ventricular dysfunction (LVEF <30%)
- •Significant non-mitral valvular disease requiring intervention
- •Severe mitral annular calcification (MAC)
- •Presence of intracardiac or femoral venous thrombus or thrombus in the inferior vena cava
- •Cerebrovascular events (TIA, CVA) or thromboembolic events within the previous 6 months.
- •Renal insufficiency
- •Inability to undergo required imaging or access
- •Inability to tolerate standard anticoagulation or antithrombotic regimen
- •Rheumatic mitral valve disease
- •Co-morbid condition limiting life expectancy or study completion
- •Pregnancy
- •Participation in another clinical trial
- •Previous device treatment for MR.
研究组 & 干预措施
Anchord Device
Anchord device implantation
干预措施: Anchord device implantation (Device)
结局指标
主要结局
Incidence of device or procedure related major adverse events [Safety]
时间窗: 30 days post-procedure.
Freedom from device- or procedure-related major adverse events.
Number of Successful device implantation assessed by imaging [Technical Success]
时间窗: Day 0 - Procedure day
Successful delivery, deployment, and secure fixation of the device assessed during the procedure.
次要结局
- MR reduction(30 days)
- NYHA class(90 days post procedure)