NL-OMON50870招募中不适用
Assessment of the safety and performance of the HARPOON* Beating Heart Mitral Valve Repair System; a multi-center post-market study (The ASCEND Study). - HARPOON ASCEND study
HARPOON Medical, an indirect wholly-owned subsidiary of Edwards Lifesciences Corporation0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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 至 99（—）
入选标准
- •Each subject is required to meet all of the following inclusion criteria:
- •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
- •A subject meeting any of the following criteria shall be excluded:
- •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
- •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
研究者
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