A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording.
研究概览
简要总结
This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history of atrial fibrillation.
详细描述
Patients with a dilated left atrium (left upper chamber of the heart) that undergo mitral valve surgery may be at risk for the development of atrial fibrillation after surgery.
Atrial fibrillation (also known as "A-Fib" or AF) is an abnormal heart rhythm which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain and/or shortness of breath. AF patients are at a higher risk of developing a stroke.
Participants who sign informed consent will be randomized into one of two groups by chance (as in the flip of a coin).
Approximately 77 patients will undergo their mitral valve operation along with Pulmonary Vein Isolation (a treatment group) and 77 patients who do not undergo Pulmonary Vein Isolation at the time of their mitral valve surgery (a control group).
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
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
- Single (Outcomes Assessor)
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
- •Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium
排除标准
- •History of Atrial Fibrillation
- •Need for emergent cardiac surgery
- •Previous cardiac surgery
- •Preoperative need for an intraaortic balloon pump or intravenous inotropes
- •Current diagnosis of active endocarditis
- •Mental impairment/or experience other conditions which may not allow subject to understand nature
- •Significance and scope of study
- •Pregnancy
研究组 & 干预措施
1
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.
干预措施: Pulmonary Vein Isolation (Procedure)
2
The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation
结局指标
主要结局
Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording.
时间窗: 12 months
次要结局
未报告次要终点