NCT05648838已完成不适用
The Study for Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of Functional Tricuspid Regurgitation : Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study
Tau-MEDICAL Co., Ltd.10 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年7月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 10
- 主要终点
- change of tricuspid regurgitation grade (1)
研究概览
简要总结
Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
详细描述
The study for evaluation of safety and efficacy of Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilot study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged 20 years or above
- •Target of Thoracic Surgery for TR and patients above the severe level on the criteria presented in the Classification of TR Grade based on echocardiogram, among those with TR, for whom a surgical treatment has been decided
- •An individual who voluntarily agreed to the participation in the clinical trial and signed the written consent
- •An individual who is able to understand and comply with the instructions and who can participate in the period before the clinical trial
排除标准
- •Uncontrolled hyperthyroidism
- •A recent formation of soft blood clot or embolic material
- •Uncorrected coagulopathy
- •Prohibition of anticoagulant agents
- •Previous insertion of a device such as an Implantable Cardioverter Defibrillator (ICD) or a pacemaker
- •Presence of malignant tumor or benign tumor such as myxoma in the heart
- •Presence of a symptom of active infection
- •Chronic pulmonary disease
- •Congenital tricuspid valve insufficiency
- •Pregnant or lactating mother, or a female patient planning pregnancy during the period of clinical trial, or a female not using an approved contraceptive with the possibility of pregnancy
- •Participation in another clinical trial 30 days prior to the screening
- •In addition, anyone showing a clinical finding deemed to be unsuitable for the clinical trial by the Principal Investigator or the Investigator
研究组 & 干预措施
Pivot Balloon
Experimental
mornitoring with transcatheter Tricuspid Regurgitation reduction system
干预措施: Pivot Balloon Catheter (Device)
结局指标
主要结局
change of tricuspid regurgitation grade (1)
时间窗: immediately after the procedure
check the success of surgery /measure the size of the TR area
change of tricuspid regurgitation grade (2)
时间窗: immediately after the procedure
examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
次要结局
- change of tricuspid regurgitation valve hemodynamics(within 24 h of insertion)
- evaluate the efficacy based on the function of early diagnosis (2)(within 24 h of insertion)
- evaluate the efficacy based on the function of early diagnosis (1)(within 24 h of insertion)
研究者
Seung-Whan Lee,MD,PhD
Professor
Asan Medical Center
研究点 (10)
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