Cryo Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,385
- 试验地点
- 160
- 主要终点
- Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months
研究概览
简要总结
Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry
详细描述
The Cryo Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to evaluate and describe clinical performance and safety data in a broad patient population treated with a commercially available Arctic Front™ Family of Cardiac Cryoablation Catheters (hereafter referred to as "Arctic Front™ Cardiac Cryoablation Catheter System"). The cryoballoon ablation(CBA) procedure will be performed according to routine hospital practice. The study is expected to have a 24 month enrollment period. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.
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
- •Subject is ≥ 18 years of age or minimum age as required by local regulations
- •Planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter
- •Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
排除标准
- •Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
- •Subject with exclusion criteria required by local law
结局指标
主要结局
Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months
时间窗: 12 Months
Estimate the 12 month freedom from AF recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System
Freedom from Atrial Arrhythmia at 12 Months
时间窗: 12 Months
Estimate the 12 month freedom from AF / Atrial Flutter (AFL)/ Atrial Tachycardia (AT) using the Arctic Front™ Cardiac Cryoablation Catheter System.
Freedom from Arrythmias at 12 months
时间窗: 12 Months
Estimate the 12-month freedom from arrythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters.
Freedom from Device / Procedure Related Adverse Events
时间窗: 12 Months
Estimate device and procedure-related adverse events for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12 months.
次要结局
未报告次要终点