EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
研究概览
简要总结
Prospective non-randomized, single arm trial to further evaluate the safety and performance of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial space during epicardial diagnostic or therapeutic (ablation) procedures.
详细描述
Prior to enrolment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be enrolled in the study by the local principal investigator after informed consent is obtained.
As EpiAccess is only used for the access portion of electrophysiology procedures, the safety, performance and effectiveness endpoints are acute from the time of needle insertion to pericardial space access (guidewire insertion into the pericardial sac). Patients will be followed until hospital discharge. Follow-up clinical examinations will be performed in accordance with institutions' standard of care. No special tests are required for this device. Patients' completion of study will occur at the time of their hospital discharge, or earlier if patient did not complete the study.
The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as defined in this protocol, after enrolment of 10 or more patients, compared to existing data from the literature presenting epicardial access procedure results during sub-xyphoid (minimally invasive) surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 18 years of age or older
- •Pericardial access is clinically indicated
- •Patient is willing and able to provide written informed consent
排除标准
- •Patient with history of cardiac or pericardial surgery in the past 6 months
- •Patient with history of chronic pericarditis
- •Myocardial infarction within 4 weeks prior to procedure
- •Class IV NYHA (New York Heart Association) heart failure symptoms
- •Cerebrovascular accident within previous 6 months
- •Known carotid artery stenosis greater than 80%
- •Presence of thrombus in the left atrium
- •Coagulopathy
- •Severe Hepatic Dysfunction or Enlargement
- •Life expectancy less than 6 months
- •Patient is enrolled in another clinical trial
- •Patient is pregnant
结局指标
主要结局
Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
时间窗: Through discharge / approx 4 days
EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.
次要结局
- Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System(access through procedure completion)
- Percentage of Participants With a Pericardial Effusion of >80ml(Access through discharge/approximately 4 days)