A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System (MAGELLAN)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 13
- 主要终点
- Number of Participants With Major Complications
研究概览
简要总结
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug
- •Other inclusion criteria
排除标准
- •Previous surgical or catheter ablation to treat AF
- •Permanent AF
- •Uncontrolled or unstable medical conditions
- •Other exclusion criteria
研究组 & 干预措施
Mesh
Ablation with HD Mesh Ablation System
干预措施: HD Mesh Ablation System (Device)
Drug
Treatment with anti-arrhythmic drugs
干预措施: Anti-arrhythmic drugs (Drug)
结局指标
主要结局
Number of Participants With Major Complications
时间窗: 12 months
A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.
Number of Participants With Serious Atrial Fibrillation Events
时间窗: 12 months
Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.
Number of Participants With Freedom From Symptomatic Atrial Fibrillation
时间窗: 12 months
Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.
次要结局
- Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.(12 months)
- Number of Participants With Acute Procedural Success in Mesh Treated Patients.(During the mesh ablation procedure)