NCT05854095已完成不适用
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat Functional Tricuspid Regurgitation : Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study
Tau Pnu Medical Co., Ltd.20 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2023年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 20
- 主要终点
- Assessment of Acute phase safety
研究概览
简要总结
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation
详细描述
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tri cuspid regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilo t 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
- Treatment
- 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
- •Patients with clinical symptoms (Symptomatic) whose degree of tricuspid regurgitation using echocardiography meets the criteria of Severe or higher presented in the TR grade classification table
- •Short-term treatment using a catheter is required (expected to be effective) by a local site heart team including at least one cardiothoracic (cardiovascular) specialist and at least one thoracic surgeon each, and clinical symptoms of NYHA Class Ⅱ or higher person who falls under
- •In the screening test, A person who can confirm the possibility of reducing tricuspid valve regurgitation by inserting that 'Pivot Balloon' (Clinical Trial Approval No. 1327), etc.) through the same access path as the 'Pivot Bridge', a clinical trial medical device
- •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
- •Those who had experience with anticoagulant use prior to participation in this clinical trial and who were treated with major bleeding (minor bleeding such as nosebleeds that can be hemostasis not applicable) due to anticoagulant use at this time or accompanied by severe anemia requiring hospitalization one with experience
- •Previous insertion of a device such as an Implantable Cardioverter Defibrillator (ICD) or a pacemaker
- •Those who is judged to have little possibility of reducing tricuspid valve regurgitation by inserting a balloon-type device (e.g. ASD sizing balloon, pivot balloon, etc.) through the same access route as the clinical trial medical device 'Pivot Bridge'
- •Persons with an anatomical structure that cannot be inserted through the corresponding route
结局指标
主要结局
Assessment of Acute phase safety
时间窗: immediately after the procedure
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
次要结局
- Efficacy endpoint-1: Changes of hemodynamics(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(1)(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(2)(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(3)(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(8)(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(10)(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(4)(within 1week of implant)
- Efficacy endpoint-2: Technical feasibility and TR grade changes(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(5)(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(9)(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(11)(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(7)(within 1week of implant)
- Efficacy endpoint-1: Changes of hemodynamics(6)(within 1week of implant)
- Assessment of short-term safety(within 1week of implant)
研究者
Joo Yong Hahn
Professor
Samsung Medical Center
研究点 (20)
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