Prophylactic Limited Left Sided Maze Procedure to Prevent Post-operative Atrial Fibrillation in Adult Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of Documented Post-operative Atrial Fibrillation
研究概览
简要总结
This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.
详细描述
This is a prospective, single site, randomized, small feasibility study using a FDA approved device for a new indication. Subjects undergoing a CABG, AVR, or CABG/AVR will be randomized 1 to 1 to a control or treatment group. The control group will undergo their index cardiac surgery procedure only. The treatment group will undergo their index cardiac procedure along with a limited left sided maze procedure. The maze procedure will be done with the Atricure synergy ablation system. This is an FDA approved device that will be used for this new indication.
The left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage.
A total of 60 subjects will be enrolled in this study at a single site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective cardiac surgery
排除标准
- •History of AF/Aflutter
- •Less common cardiac surgeries:
- •aortic root replacement
- •aortic dissections
- •pericardectomies
- •off-pump procedures
- •redo procedures
- •Subjects with existing pacemakers, AICD
- •Vulnerable population
- •Emergent surgery
- •Currently participating in investigational drug or device study.
- •Subjects currently on antiarrhythmic drugs Class I and III including amiodarone.
结局指标
主要结局
Incidence of Documented Post-operative Atrial Fibrillation
时间窗: From date of index surgical procedure to date of discharge, on average 1 week.
Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.
次要结局
- Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group(immediately after procedure/surgery up to discharge from the hospital, average 1 week)
- Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation.(during the procedure/surgery, up to 8 hours)
- Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group(immediately after procedure/surgery up to discharge from the hospital, on average 1 week)
研究者
Charles Willekes
Cardiothoracic Surgeon
Spectrum Health Hospitals