Epicardial Access Study With Rook (EASY-R)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Successful Epicardial Access
研究概览
简要总结
The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access.
Participants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure.
详细描述
This trial is a confirmatory trial for the Circa Scientific Rook® Epicardial Access Kit for accessing the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in adult patients. The purpose of this study is to confirm the safety and establish the efficacy of the Circa Scientific Rook® Epicardial Access Kit as a pericardial access device. The Rook® Epicardial Access Kit will be used to gain access the epicardial surface of the heart via a subxiphoid approach in adult patients with a normal, non-distended pericardial space.
Access success of the test device to the pericardial space and occurrence of CEC-adjudicated device and procedure related adverse events will be assessed in relation to complication rate existing data from the literature presenting epicardial access procedure results during subxiphoid (minimally invasive) surgical procedures. This is a prospective, single-arm, non-randomized study.
The primary endpoint is successful pericardial access through the use of the Circa Scientific Rook® Epicardial Access Kit, achieving guidewire access to the pericardial space as confirmed during the procedure by standard x-ray technique. The safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through hospital discharge or up to 4 days post procedure, whichever comes first. Additional endpoints include speed of access, ease of use and human factors data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient is clinically indicated to undergo a procedure that requires percutaneous access to the normal, non-distended, pericardial space.
- •Patient is willing and able to provide written informed consent.
排除标准
- •Subject is younger than 18 years of age
- •Previous cardiac surgery
- •Myocardial infarction within 4 weeks prior to procedure
- •Class IV NYHA (New York Heart Association) heart failure symptoms
- •Subject with an active systemic infection
- •Known carotid artery stenosis greater than 80%
- •Presence of thrombus in the left atrium
- •Congenital absence of a pericardium
- •Coagulopathy
- •Hemodynamic Instability
- •Acute conditions (i.e. electrolyte abnormality, acute ischemia, drug toxicity)
- •Severe hepatic dysfunction or enlargement
- •Subject has Body Mass Index > 40
- •Life expectancy less than 6 months
- •Subject is pregnant
- •Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
- •Subject has known or suspected allergy to contrast media
- •Subject is known to have pericardial fibrosis, pericardial adhesions, or prior failed epicardial access
结局指标
主要结局
Successful Epicardial Access
时间窗: During procedure.
The number and percentage of patients in which successful epicardial access is achieved
次要结局
- Rate of Use Errors(During procedure.)
- Speed of Access(During procedure.)