Minimally Invasive Surgical Ablation for Standalone Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- efficacy - sinus rhythm
研究概览
简要总结
Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone atrial fibrillation (AF). This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF.
详细描述
Atrial fibrillation (AF) patients with a previous stroke are often at a high risk of recurrent stroke and bleeding. Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone AF. This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF. Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial Doppler measurement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age > 18 years
- •Patients with paroxysmal, or persistent/long-standing persistent AF according to the standard EHRA definition.
- •Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication.
- •Absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
排除标准
- •AF secondary to a reversible cause (i.e., thyreopathy, etc.) Indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.)
- •Severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the AF is clearly of secondary etiology
- •Known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)
结局指标
主要结局
efficacy - sinus rhythm
时间窗: 1 year
Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)
次要结局
- periprocedural complications - surgery(30 days after surgery)
研究者
Hong Liu
Investigator of the First Hospital of Nanjing Medical University
Nanjing Medical University