iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 91
- 试验地点
- 6
- 主要终点
- Primary outcome - freedom from AF/AT/AFL
研究概览
简要总结
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).
详细描述
This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ 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
- 是
入选标准
- •Subject is ≥ 18 years of age
- •Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System
- •Subject willing to comply with study requirements and give informed consent.
排除标准
- •In the opinion of the Investigator, any known contraindication to an atrial ablation procedure with the Adagio iCLAS™ Cryoablation System as indicated in the device Instructions For Use (IFU).
- •Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor.
- •Any other condition that, in the judgment 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 one year, extensive travel away from the research center)
研究组 & 干预措施
iCLAS Cryoablation arm
all subjects will receive a cryoablation procedure with the iCLAS System and be followed up for 12-month
干预措施: cryoablation procedure using the iCLAS Cryoablation System (Device)
结局指标
主要结局
Primary outcome - freedom from AF/AT/AFL
时间窗: 12 months
Freedom from Atrial Arrhythmia at 12-months
Primary outcome - freedom from Device/Procedure Related Adverse Events
时间窗: during procedure and up to 12-month follow up
Freedom from Device / Procedure Related Adverse Events during and after the ablation procedure through12-month follow up
Primary outcome - freedom from AF
时间窗: 12 months
Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period.
次要结局
未报告次要终点