Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 12
- 主要终点
- Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs).
研究概览
简要总结
This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a history of symptomatic Persistent AF and a left atrium (LA) > 4cm or Long Standing Persistent AF as defined by the HRS/EHRA/ECAS expert consensus statement
- •Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)
- •Patient is mentally able and willing to give informed consent
排除标准
- •Patient has longstanding persistent AF > 10 years
- •Patient presenting with paroxysmal AF
- •Patient with persistent AF and a LA-diameter ≤ 4cm
- •AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
- •Patient underwent previous ablation procedure or heart surgery
- •Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others)
- •Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, Previous cardiac tamponade, Pleural adhesions, Prior thoracotomy)
- •Body mass index > 35
- •LA Diameter > 6 cm
- •Left ventricular ejection fraction < 30 %
- •Severe mitral regurgitation (>II)
- •Patient unable to undergo TransEsophageal Echocardiogram (TEE)
- •Presence of LA thrombus by TEE, CT scan, MRI or angiography
- •History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
- •Active infection or sepsis
- •Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis)
- •Contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
- •Pregnancy, planned pregnancy or breastfeeding
- •Life expectancy is less than 12 months
- •Patient is involved in another study involving an investigational drug or device
研究组 & 干预措施
Hybrid Procedure
Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.
干预措施: AtriClip® PRO LAA Exclusion System (Device)
Hybrid Procedure
Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.
干预措施: Endocardial Ablation with Catheter (Device)
Hybrid Procedure
Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.
干预措施: AtriCure Bipolar System (Device)
Catheter Procedure
Standard catheter ablation with pulmonary vein (PV) isolation (minimum lesion set) and optional additional lesions (index procedure). When required due to AF recurrence, ablation may be repeated within 6 months after the index-procedure according to clinical indications and consistent with the Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Consensus Statement
干预措施: Standard Endocardial Ablation with Catheter (Device)
Catheter Procedure
Standard catheter ablation with pulmonary vein (PV) isolation (minimum lesion set) and optional additional lesions (index procedure). When required due to AF recurrence, ablation may be repeated within 6 months after the index-procedure according to clinical indications and consistent with the Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Consensus Statement
干预措施: Repeated Endocardial ablation(s) (Device)
结局指标
主要结局
Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs).
时间窗: Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)
次要结局
- Number of subjects free from documented AF, AFL or AT episodes > 30 seconds in duration through 24 and 36 months follow-up, in the absence of Class I or III AADs.(Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure))