Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 20
- 主要终点
- Number of Subjects With Procedural Success During the First 30 Days
研究概览
简要总结
To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
详细描述
This trial is a single arm, prospective, multi-center, non-randomized and open-label post-market study that will evaluate subjects for up to 5 years post treatment.
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
- •Subject is > 18 years old
- •Presence of severe MR as read on a transthoracic echocardiographic study
- •Mitral leaflet coaptation surface is sufficient to reduce mitral regurgitation without undue leaflet tension (approximate leaflet to gap ratio of 2:1) based on the judgment of the patient eligibility committee and the operating surgeon
- •Degenerative mitral valve disease with mid-segment P2 prolapse
- •Patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation
排除标准
- •Patient is of the age where further growth is expected
- •Active endocarditis
- •Left ventricular or left atrial appendage thrombus
- •Severe mitral annular and/or leaflet calcification
- •Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen
- •Mitral stenosis
- •Functional Mitral Valve disease
- •Previous mitral valve replacement surgery
- •Fragile or thinning apex
- •Contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum)
- •Patient is pregnant or lactating
结局指标
主要结局
Number of Subjects With Procedural Success During the First 30 Days
时间窗: 30 days
Subject's procedural success at 30 days post-treatment, as measured by: Technical success (defined as implantation of at least three chords, leaving the operating room and no conversion to open heart surgery) with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs.
Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding
时间窗: 30 days
Subject's freedom from all-cause mortality, disabling stroke and life-threatening bleeding at 30 days post-implant.
次要结局
未报告次要终点