Agilis Radiofrequency Transseptal System Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Primary Safety Endpoint: Rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
研究概览
简要总结
This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP) and interventional cardiology (IC) procedures. This study will be conducted in an acute setting. Subjects will be followed through hospital discharge, and no follow-up visits will be required for this 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
- 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
- •Is able and willing to provide written informed consent prior to any clinical investigation-related procedure
- •Plans to undergo an ablation procedure in LA, LV or concomitant procedure with ablation and LAAO device implantation requiring transseptal puncture
- •Is at least 18 years of age
- •Able and willing to comply with all study requirements
排除标准
- •Currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from the study Sponsor
- •Pregnant or nursing
- •Known presence of intracardiac thrombus
- •Known existing circumferential pericardial effusion (>2 mm)
- •Previous interatrial septal patch or prosthetic atrial septal defect closure device
- •Any previous thromboembolic event with in the last 6 months
- •Known or suspected left atrial myxoma
- •Known or suspected myocardial infarction within the last two weeks
- •Unstable angina
- •Recent (within the last 3 months) cerebral vascular accident (CVA)
- •Patients with an active infection
- •Patients who do not tolerate anticoagulation therapy
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
研究组 & 干预措施
Transseptal Procedure
干预措施: Transseptal procedure with Agilis RF TSP System. (Device)
结局指标
主要结局
Primary Safety Endpoint: Rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
时间窗: During the procedure and periprocedurally
The primary safety endpoint is the rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician.
时间窗: Procedure
The primary effectiveness endpoint is the rate of successful transseptal access indicated by the physician.
次要结局
未报告次要终点