Adagio Medical VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Primary Performance Endpoint
研究概览
简要总结
The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia.
详细描述
This VT Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical VT Cryoablation System in real world clinical settings.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IC 1 Male or female the ages of ≥ 18 years
- •IC 2 Planned ablation procedure according to the indication for use of the Adagio VT Cryoablation System
- •IC 3 Subject willing to comply with study requirements and give informed consent
- •IC4 Subject has or will be receiving an ICD prior to hospital discharge
排除标准
- •EC 1 In the opinion of the investigator, any known contraindication to a ventricular tachycardia procedure with the Adagio VT Cyroablation System as indicated in the device Instructions For Use (IFU)
- •EC 2 Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor
- •EC 3 Any other condition that, in the judgement of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than six months, extensive travel away from the research center)
研究组 & 干预措施
VT Cryoablation Arm
all subjects will receive a cryoablation procedure with the VT System and be followed up for 6-month
干预措施: VT Cryoablation System (Device)
结局指标
主要结局
Primary Performance Endpoint
时间窗: 6 months
Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period
Primary Safety Endpoint
时间窗: 30 Days
Freedom from device / procedure related major adverse events (MAE) during and after the ablation procedure through 30 days follow up. MAEs include: * Death * MI * Cardiac perforation / pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion * Heart valve damage resulting in moderate to severe regurgitation * Access site complications requiring surgical intervention * Pericarditis * Heart block requiring a pacemaker implant * Other serious adverse device effects (SADEs).
次要结局
- Secondary Safety Endpoint(6 months)
- Secondary Performance Endpoint(During the procedure)