ABLATOR Brazil - Ablation Observational Study (Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 833
- 试验地点
- 12
- 主要终点
- Unsuccessful Treatment Rate
研究概览
简要总结
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of St. Jude Medical (SJM)/Abbott mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).
详细描述
The objectives of this registry are the following:
- To confirm patient safety as part of the post market surveillance study.
- To assess performance of a combination of SJM products during procedures.
- To assess the learning curve with a combination of SJM products.
- To collect operator feedback on a combination of SJM products.
All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry.
In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.
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
- •All patients who are indicated for an atrial fibrillation ablation procedure.
排除标准
- •Pregnant women
结局指标
主要结局
Unsuccessful Treatment Rate
时间窗: up to 6 and 12 months after ablation procedure
Percent of subjects with a repeat procedure
次要结局
- Death in Subjects Who Underwent an Ablation Procedure(up to 12 months after ablation procedure)
- Cardiovascular Serious Adverse Event (SAE)(up to 6 and 12 months after ablation procedure)