DRKS00022786进行中（未招募）不适用
Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND) - ASCEND
Harpoon Medical, an indirect-wholly owned subsidiary of Edwards Lifesciences Corporation, Edwards Lifesciences,0 个研究点目标入组 42 人开始时间: 2020年10月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Subject is = 18 years old
- •2. Presence of severe MR as read on a transthoracic echocardiographic study
- •3. 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
- •4. Degenerative mitral valve disease with mid-segment P2 prolapse
- •5. 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
- •1. Patient is of the age where further growth is expected
- •2. Active endocarditis
- •3. Left ventricular or left atrial appendage thrombus
- •4. Severe mitral annular and/or leaflet calcification
- •5. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen
- •6. Mitral stenosis
- •7. Functional Mitral Valve disease
- •8. Previous mitral valve replacement surgery
- •9. Fragile or thinning apex
- •10. Contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum)
- •11. Patient is pregnant or lactating
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