NCT01061931终止4 期
HD Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation - Efficiency and Safety of PV Ablation Systems
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient
研究概览
简要总结
The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.
详细描述
Primary objective:
• Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient.
Secondary objectives:
- Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI prior and within 2 days after PV ablation.
- Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI within 6 months after PV ablation.
- Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®).
- Characterization of non-neurological major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)
- Rate of iatrogenic interatrial septal defects after transseptal puncture for PV ablation.
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
- Single (Investigator)
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 with ECG-documented symptomatic paroxysmal atrial fibrillation and at least one ineffective antiarrhythmic drug treatment
排除标准
- •Previous ablation procedure for atrial fibrillation or cardiac surgery within 3 months
- •Left atrial diameter > 50mm or ejection fraction < 35%
- •Instable coronary artery disease or clinically relevant cardiac valve insufficiency
- •Hyperthyroidism, pregnancy or lactation; coumadin or heparin intolerance
- •Concomitant disease with expected lifespan < 2 years
- •Contraindications for MRI or acute cerebral infarction detected by brain MRI immediately (< 24 hours) before catheter ablation.
结局指标
主要结局
Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient
时间窗: During ablation procedure
次要结局
- Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI(6 months after catheter ablation)
- Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®)(1 year after catheter ablation)
- Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)(within 1 month after catheter ablation)
- Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation(1 year after catheter ablation)
研究者
Jochen B. Fiebach
MD
Charite University, Berlin, Germany
研究点 (2)
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