Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 199
- 试验地点
- 70
- 主要终点
- Number of Participants With Procedure and/or Device Related Stroke
研究概览
简要总结
VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of symptomatic persistent or long-standing persistent atrial fibrillation
- •Failure of at least one anti-arrhythmic drug
排除标准
- •Structural heart disease
- •Prior ablation in left atrium for AF
- •Known sensitivities (or allergy) to heparin, warfarin, contrast media
- •Contraindicated for MRI
- •Invasive cardiovascular procedure performed or planned within 3 month period of ablation procedure
研究组 & 干预措施
Ablation
Phased RF ablation
干预措施: Medtronic Phased RF Ablation System (Device)
结局指标
主要结局
Number of Participants With Procedure and/or Device Related Stroke
时间窗: 30 days
A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee
次要结局
- 6-month Post-procedure Effectiveness(6 months)
- Number of Participants With Acute Procedural Success(30 minutes)
- Number of Participants With Pulmonary Vein Stenosis(3 months)