Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 10
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
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
- •Age > 18 years
- •Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
- •Patient is willing and able to provide written informed consent.
- •Patient has a life expectancy of at least 2 years.
- •Patient is willing and able to attend the scheduled follow-up visits.
排除标准
- •Prior Cardiothoracic Surgery.
- •Patient has NYHA Class IV heart failure.
- •Evidence of underlying structural heart disease requiring surgical treatment.
- •Ejection fraction < 30%
- •Measured left atrial diameter > 6.0 cm
- •Renal Failure
- •Stroke within previous 6 months.
- •Known carotid artery stenosis greater than 80%.
- •Evidence of significant active infection or endocarditis.
- •Pregnant woman or women desiring to become pregnant in the next 24 months.
- •Presence of thrombus in the left atrium determined by echocardiography.
- •History of blood dyscrasia.
- •Contraindication to anticoagulation, based on Investigator's opinion.
- •Mural thrombus or tumor.
- •Moderate to Severe COPD
结局指标
主要结局
Primary Safety Endpoint
时间窗: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.
Absence of Atrial Fibrillation
时间窗: 12 month follow-up
Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.
次要结局
- Duration of Procedure(During index procedure)
- Number of Participants With DC Cardioversion(12 months)
- Overall Serious Device or Procedure Related Adverse Event Rate(12 month follow-up)
- Absence of Atrial Fibrillation(After the 3 month blanking period through twelve month follow-up.)
- Number of Participants With Reintervention to Address Atrial Dysrhythmia(12 months)
- Acute Procedure Success(Upon completion of the index procedure, up to ten hours)
- Improvement in AF(12 months)