AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 9
- 主要终点
- Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
研究概览
简要总结
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac 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
- •Subject is greater than or equal to 18 years of age
- •Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
- •Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
- •Mitral valve repair or replacement
- •Aortic valve repair or replacement
- •Tricuspid valve repair or replacement
- •Coronary Artery Bypass procedures
- •Atrial Septal Defect Repair
- •Patent Foramen Ovale closure
- •Subject's Left Ventricular Ejection Fraction ≥ 30%
- •Subject is able and willing to provide written informed consent and comply with study requirements
- •Subject has life expectancy of at least 1 year
排除标准
- •Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure
- •Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
- •Wolff-Parkinson-White syndrome
- •Prior cardiac surgery (Redo)
- •Class IV NYHA heart failure symptoms
- •Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
- •Documented MI within 6 weeks prior to study enrollment
- •Need for emergent cardiac surgery (i.e. cardiogenic shock)
- •Known carotid artery stenosis greater than 80%
- •LA size greater than or equal to 8cm
- •Current diagnosis of active systemic infection
- •Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
- •Pregnancy or desire to get pregnant within 12-months of the study enrollment
- •Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- •Renal failure requiring dialysis or hepatic failure
- •Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
- •Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders
研究组 & 干预措施
AtriCure Bipolar System
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
干预措施: AtriCure Bipolar System (Device)
结局指标
主要结局
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
时间窗: 30 days Post Procedure
Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.
Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
时间窗: 6 Months Post Procedure
次要结局
- Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.(6 Months Post Procedure)
- Composite 6-month Post-procedure Major Adverse Event Rate.(6 Months Post Procedure)