Treatment Success With the CoolLoop Cryoablation System - Post-Market Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- afreeze GmbH
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Incidence of serious adverse events
研究概览
简要总结
This clinical study evaluates the safety and efficacy of the treatment with the CoolLoop® cryoablation System (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted) over a follow-up period of 36 months.
A further aim of this study is to evaluate the average duration of procedure and fluoroscopy times.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥ 18 years
- •atrial fibrillation: permanent AF excepted
- •ECG documented AF within the last 6 months
- •patients planned for an ablation procedure and suitable and planned for treatment with the CoolLoop® cryoablation system
- •signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment (patient has received a copy of the ICF)
排除标准
- •indication that the vascular system is not accessible through the left or right groin.
- •indication that a transseptal puncture cannot be performed.
- •any previous ablation or surgery due to AF.
- •important comorbidities such as cardiovascular events within six months of enrollment or high-risk surgical patients.
- •pregnant women at the time of the cryoablation procedure.
- •any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
- •participation in interventional trials for cardiovascular devices or drugs.
结局指标
主要结局
Incidence of serious adverse events
时间窗: 36 months follow-up period
Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation
Freedom from atrial fibrillation (efficacy) at 36 months post-ablation
时间窗: 36 months follow-up period
Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 36 months post-ablation
次要结局
- Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation(12 and 24 months post-ablation)
- Total procedure time(Estimated timeframe up to 4 hours)
- CoolLoop procedure time(Estimated timeframe up to 2 hours)
- Adverse Events (AEs) of special interest(36 months follow-up period)
- Cumulative cryoablation time(Estimated timeframe up to 1 hour)
- Acute procedure success(36 months follow-up period)
- Total fluoroscopy time(Estimated time frame up to 1 hour)
- CoolLoop fluoroscopy time(Estimated timeframe up to 30 minutes)