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 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- HARPOON Medical, an indirect wholly-owned subsidiary of Edwards Lifesciences Corporation
- 入组人数
- 20
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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
结局指标
主要结局
未指定
相似试验
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)Severe Degenerative Mitral Regurgitation due to Mid-segment Posterior Leaflet ProlapseDRKS00022786Harpoon Medical, an indirect-wholly owned subsidiary of Edwards Lifesciences Corporation, Edwards Lifesciences,42
招募中
不适用
Effect of the herbal capsule containing aloe vera, flax leaves for curing constipation and comparing it with magnesium hydroxideComparison with Magnesium HydroxideConstipation.IRCT20080901001165N38Bagheiat-allah University of Medical Sciences120
已完成
2 期
Haploidentical hematopoietic stem cell transplantation for the treatment of severe aplastic anemia patients.IRCT20140818018842N29Tehran University of Medical Sciences10
尚未招募
不适用
Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates (AB1MALTISC)lung cancerlung carcinoma100386661002910710038737NL-OMON56952Creo Medical Limited10
尚未招募
不适用
Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue (AB1MALT)lung cancerlung carcinoma100729901002910710038737NL-OMON56949Creo Medical Limited10