Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 29
- 主要终点
- Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
研究概览
简要总结
This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat permanent AF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines.
- •Concomitant indication (other than AF) for open-heart surgery for one or more of the following:
- •Mitral valve repair or replacement
- •Aortic valve repair or replacement
- •Tricuspid valve repair or replacement
- •Atrial septal defect (ASD) repair
- •Patent foramen ovale (PFO) closure
- •Coronary artery bypass procedures
- •Greater than or equal to 18 years of age
- •Able and willing to comply with study requirements by signing a consent form
- •Must be able to take the anticoagulant warfarin (Coumadin)
排除标准
- •Wolff-Parkinson-White syndrome
- •NYHA Class = IV
- •Left ventricular ejection fraction ≤ 30%
- •Need for emergent cardiac surgery (i.e. cardiogenic shock)
- •Previous ablation for atrial fibrillation, AV-nodal ablation, or surgical Maze procedure
- •Contraindication for anticoagulation therapy
- •Left atrial diameter > 7.0 cm
- •Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- •Renal failure requiring dialysis or hepatic failure
- •Life expectancy of less than one year
- •Pregnancy or desire to be pregnant within 12 months of the study treatment.
- •Current diagnosis of active systemic infection
- •Documented MI 6 weeks prior to study enrollment
结局指标
主要结局
Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
时间窗: 30 days post procedure or hospital discharge
Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.
Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted at 6 Months Postoperatively.
时间窗: 6 months
Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.
次要结局
- Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 6 Months(6 months)
- Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure(6 months)