To Treat Cardiac Arrhythmias Patients with Cardiac Cryoablation Catheters in India- "Cryo Global Registry study"
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 3,500
- 试验地点
- 8
- 主要终点
- 1.Freedom from atrial fibrillation (AF)
研究概览
简要总结
The Arctic FrontTM Family of Cardiac CryoAblation Catheters are used for the treatment of patients with atrial fibrillation (AF). These catheters facilitate anatomical isolation of the pulmonary veins from the left atrium with the application of a 23mm or 28mm cryoballoon at the pulmonary vein ostium. The cryoballoon ablates with minimal disruption of the endothelium, creates relatively discrete lesions, and preserves the myocardial architecture, followed by replacement with fibrous tissue through the Joule-Thomson effect.The Freezorâ„¢ Family of Cardiac Cryoablation Catheters are used for the focal cryoablation of cardiac tissue to treat cardiac arrhythmias.
Approved indications for use for each market-released product are defined in the respective labeling for each geography.
This clinical study has been designed to provide valid scientific evidence on the safety and effectiveness of the Arctic Frontâ„¢ and Freezorâ„¢ Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Frontâ„¢ Cardiac Cryoablation Catheter System) in a global setting. Previous clinical studies have reported on safety and efficacy of these devices. Medtronic has published numerous studies including the STOP AF Post-Approval Study, Cryo4Persistent AF, ICY-AVNRT, and STOP AF First. There are also several investigator-initiated single center publications. The Cryo Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this registry is to describe clinical performance and safety data in a broad patient population treated with Arctic Frontâ„¢ Cardiac Cryoablation Catheter System. To assess clinical performance and safety of the system, study objectives will estimate 12-month efficacy and procedural safety. Additionally, study objectives will characterize the ablation procedure, Quality of Life (QoL), and global standard of care for AF ablation patients having cryoablation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject is ≥ 18 years of age or minimum age as required by local regulations
- •Planned procedure using commercially available Arctic Frontâ„¢ and Freezorâ„¢ Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Frontâ„¢ Cardiac Cryoablation Catheter System)
- •Willing to comply with study requirements and give informed consent (IC) (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
1.Freedom from atrial fibrillation (AF)
时间窗: 1 Year
recurrence using the Arctic Frontâ„¢ Family of Cardiac Cryoablation Catheters
时间窗: 1 Year
2.Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT) recurrence using the Arctic Frontâ„¢ Family of Cardiac Cryoablation Catheters
时间窗: 1 Year
3.Freedom from arrhythmias treated using the Freezorâ„¢ Family of Cardiac Cryoablation Catheters
时间窗: 1 Year
Catheter System
时间窗: 1 Year
4. Device and procedure related adverse events for
时间窗: 1 Year
cryoablation using the Arctic Frontâ„¢ Cardiac Cryoablation
时间窗: 1 Year
次要结局
- 1. Characteristics of the cryoablation procedure(2. Change in quality of life (QoL))