A Comparison of Traditional Arrhythmia Assessment With the Use of Continuous Monitoring to Quantify Postoperative Arrhythmia Burden Following Surgical Treatment of Atrial Fibrillation- Medtronic Reveal XT Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals
研究概览
简要总结
While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years, virtually all of the historical series reported only the recurrence of symptomatic AF and have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use of traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative arrhythmia burden following surgical treatment for AF in patients undergoing either lone or concomitant heart surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing planned, elective AF surgery, either as a stand-alone procedure or as a concomitant cardiac operation.
- •Patients will have either a Cox-Maze procedure (full-biatrial lesion set) or surgical pulmonary vein isolation (PVI).
- •Patients 18 years or older.
- •All eligible patients will be considered, regardless of gender or race.
- •Patients able and willing to provide informed consent and willing to comply with the required interval follow-up.
排除标准
- •Patients with a preoperative permanent pacemaker.
- •Patients with a projected lifespan of less than six months.
- •Patients requiring emergent cardiac surgery.
- •Patients unwilling or unable to give written informed consent.
- •Patients undergoing a right atrial or left atrial lesion set procedure.
结局指标
主要结局
Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals
时间窗: ILR monitoring obtained at 3, 6 and 12 months
Freedom From Atrial Tachyarrhythmias (ATAs)
时间窗: ILR monitoring at 12 months
次要结局
未报告次要终点
研究者
Jennifer Bell
Manager of Research, Cardiothoracic Surgery
Washington University School of Medicine