Norwegian Randomized Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation (NO PERS-AF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 3
- 主要终点
- The freedom of any atrial arrhythmias at 12 months.
研究概览
简要总结
This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.
详细描述
The purpose of this randomized clinical trial is to compare the efficacy and safety of pulmonary vein isolation with either the second generation cryoballoon (Arctic Front Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia recurrence at 12 months.Treatment success will be evaluated by using 12-lead electrocardiography and 7-day Holter recording.
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
- •Patients plan to undergo pulmonary vein isolation as the first procedure for symptomatic persistent atrial fibrillation (>7 days) and longstanding persistent atrial fibrillation (> 12 months, but ≤ 3 years) who are refractory to at least one class I or class III antiarrhythmic drug and required at least one electrical or pharmacologic cardioversion.
- •Subject is at least 18 and ≤ 75 years old.
- •Subject is able and willing to give informed consent.
排除标准
- •Subject has paroxysmal atrial fibrillation (< 7days) or persistent atrial fibrillation with duration > 3 years.
- •Subject has any previous left atrial ablation procedure or surgery, including pulmonary vein isolation.
- •Subject has presence of an intracavitary thrombus.
- •Subject has uncontrolled heart failure.
- •Subject has severe valvular disease.
- •Subject has the left atrial diameter > 60 mm confirmed by echocardiography.
- •Subject has contraindications to systemic anticoagulation with heparin or oral anticoagulants.
- •Subject has known cryoglobulinaemia.
- •Subject has severe renal dysfunction.
- •Subject who is or may potentially be pregnant.
- •Subject has unstable angina pectoris.
- •Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
- •Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension.
结局指标
主要结局
The freedom of any atrial arrhythmias at 12 months.
时间窗: 12 months
The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration \> 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording).
次要结局
- Symptoms related to atrial fibrillation.(12 months.)
- Serious adverse events.(12 months.)
- Fluoroscopy time(12 months)
- Quality of life - Short Form (SF-36) Heath Survey(12 months.)
- Ablation time(12 months)
- Procedure duration(12 months)
- The burden of atrial fibrillation(12 months.)
- Quality of life affected by atrial fibrillation.(12 months.)
- Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias.(12 months.)
- The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter.(12 months.)