NCT00785902撤回3 期
AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
研究概览
简要总结
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.
研究设计
- 研究类型
- Interventional
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 persistent 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
- •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
- •Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
- •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 8 cm
- •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
结局指标
主要结局
The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge
次要结局
- The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
- The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.
研究者
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