NCT00566787已完成3 期
A Prospective, Multi-center Study With Case Matched Controls to Evaluate the Safety and Efficacy of the AtriCure Bipolar System for the Treatment of Continuous Atrial Fibrillation as Adjunct Therapy to Elective Open Heart Surgery
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 20
- 主要终点
- Primary efficacy endpoint is the proportion of treated patients who are free of atrial fibrillation without the need for anti-arrhythmic agents at the six-month follow-up visit.
研究概览
简要总结
RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subject between 18 to 80 years of age
- •Subject is scheduled to undergo elective cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including:
- •coronary artery bypass and/or
- •mitral valve surgery (repair or replacement)
- •aortic valve surgery (repair or replacement)
- •tricuspid valve surgery (repair or replacement)
- •Left Ventricular Ejection Fraction ≥ 30%
- •Subject is willing and able to provide written informed consent
- •Subject has a life expectancy of at least 2 years
- •Subject is willing and able to return for scheduled follow-up visits
- •TREATMENT SUBJECTS ONLY: Subject has a 3 month documented history of continuous atrial fibrillation
- •CONTROL SUBJECTS ONLY: Subject is not in atrial fibrillation at time of surgery
排除标准
- •Lone AF without indication(s) for concomitant CABG and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery
- •Prior cardiac surgery (Redo -including previous ablation)
- •Patient requires atrial septal defect repair or any other concomitant open-heart procedure, other than CABG and/or mitral valve surgery; aortic valve surgery, tricuspid valve surgery or double valve surgery
- •Serum creatinine concentration greater than 2.0 mg/dl
- •Class IV NYHA heart failure symptoms and/or Class IV CCS anginal symptoms
- •Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit
- •Active infection
- •Known carotid artery stenosis greater than 80%
- •Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
- •A known drug and/or alcohol addiction
- •Mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study
- •Pregnancy or desire to get pregnant within 12 months of study enrollment
- •Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
结局指标
主要结局
Primary efficacy endpoint is the proportion of treated patients who are free of atrial fibrillation without the need for anti-arrhythmic agents at the six-month follow-up visit.
时间窗: 6 months
The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure.
时间窗: 30 days
次要结局
- The secondary efficacy endpoint is the proportion of patients in the treatment group who are free of atrial fibrillation independent of the need for anti-arrhythmic drugs.(6 Months)
- The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours)(Discharge)
研究者
研究点 (20)
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