Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 22
- 主要终点
- Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
研究概览
简要总结
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)
A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
详细描述
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)
A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
The research study was conducted in the EU and Canada. The protocol and the corresponding NCT number is as follows:
NCT02462980 (Protocol CL-AF-001, Site Ontario, Canada Dr. Verma = PI)
The above record was combined into one as both protocols are essentially identical (one is post market [EU] and the other pre-market [Canada] and one study report will be written that encompasses the data/results for both protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for an ablation of persistent atrial fibrillation
排除标准
- •Any duration of continuous AF lasting longer than 12 months
- •Previous AF ablation
- •Significant structural heart disease
- •Previous cerebral infarct
- •Major bleeding disorders
- •Pregnant or lactating
结局指标
主要结局
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
时间窗: 24 hours
MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.
次要结局
- Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.(6, 9, and 12 Months)
- Number of Participants Who Experienced at Least One Adverse Events.(12 Months)
- Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.(24 hours)