EASYER (EpiAccess SYstem Registry) - A Post Market Observational Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Number of Participants with Adverse Events as Measure of Safety
研究概览
简要总结
The objective of the Registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the EpiAccess system.
详细描述
The Registry will be a prospective non-randomized single-arm trial of up to 150 patients enrolled in up to ten (10) centers in the United States. The overall duration of the registry is estimated to be 18 months per site. For the patients the registry duration will be from the time of procedure until discharge from the hospital, estimated to be approximately four (4) days.
Prior to enrollment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be considered enrolled in the registry after written informed consent is obtained.
As EpiAccess is only used for the access portion of the procedure, the safety performance and effectiveness endpoints are acute from the time of needle insertion until pericardial sac access is achieved. Follow up clinical examinations will be performed according to institutional standard of care. No special tests are required for this device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who have any condition which contraindicates pericardial access or who have any condition specified in the Contraindications section of the Instructions for Use. This includes:
- •Previous cardiac surgery or myocardial infarctions resulting in pericardial fibrosis
- •Congenital absence of a pericardium
- •Absence of a free epicardial space
- •Patients with active infection
- •History of chronic pericarditis
- •Patient requiring anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
- •Patient not in normal sinus rhythm
- •Presence of thrombus in the left atrium
- •Coagulopathy
- •Known allergy to contrast media
结局指标
主要结局
Number of Participants with Adverse Events as Measure of Safety
时间窗: Up to 4 days post procedure (or until time of discharge)
Number of Participants with Adverse Events as Measure of Safety
次要结局
- Health Economics(Up to 4 days post procedure (or until time of discharge))