NCT04061837Unknown不适用
To Evaluate the Effectiveness and Safety of MitralStitch Mitral Valve Repair System - a Clinical Application of New Technology
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年8月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The occurrence rate of major adverse event after 30 days of the intervention
研究概览
简要总结
The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.
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
- •The age of patient is ≥18yrs;
- •Severe mitral regurgitation patients (The area of central regurgitation exceeds 40% of left atrial area or holosystolic eccentric regurgitation; VC≥0.07cm；regurgitant volume ≥60ml；RF ≥50%; EROA≥0.4cm2 (Satisfy any condition).
- •LVESD≤60mm, LVEF≥25%, small incision surgery of chest can be tolerated.
- •The subject was informed of the clinical application nature of the new technology and agreed to participate in all requirements of the clinical application of the new technology, signed the ICF and agreed to complete the follow-up and the inspection required during the follow-up period.
排除标准
- •Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology.
- •Subjects with active endocarditis or rheumatic mitral valve disease.
- •Life expectancy <1 year for cardiac or other malignant tumors.
- •Participate in other clinical trial
- •In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.
研究组 & 干预措施
MitralStitch repair system
Experimental
Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd
干预措施: MitralStitch (Device)
结局指标
主要结局
The occurrence rate of major adverse event after 30 days of the intervention
时间窗: 30days
The occurrence of complications associated with any device or operation, including but not limited to: death, emergency surgery, severe pericardial tamponade requiring pericardiac puncture or surgery, bleeding, and surgically related stroke.
次要结局
- The success rate of operation(Before discharge, an average of 7 days)
- Incidence of major adverse events after device implantation(12months)
- The success of device(Immediately after repair)
- The classification of mitral regurgitation(1/6/12 months)
研究者
Jian Yang
Deputy chief surgeon
Xijing Hospital
研究点 (1)
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