NCT04784013已完成4 期
Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 5
- 主要终点
- Procedural time
研究概览
简要总结
This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or <7days) or persistent AF (persistent AF is defined as having an AF episode >7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial)
- •Patients willing to sign informed consent
排除标准
- •Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode >1yr)
- •Previous ablation for AF
- •Left atrium antero-posterior diameter >50 mm (parasternal long axis view, PLAX)
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
- •Left ventricular ejection fraction <35%.
- •Cardiac surgery within the previous 90 days.
- •Expecting cardiac transplantation or other cardiac surgery within 180 days.
- •Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
- •Documented history of a thromboembolic event within the previous 90 days.
- •Diagnosed atrial myxoma.
- •Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- •Women who are pregnant or who plan to become pregnant during the study.
- •Acute illness or active infection at time of index procedure
- •Advanced renal insufficiency
- •Unstable angina.
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation.
- •Life expectancy less than 1 year.
- •Presence of a condition that precludes vascular access.
- •Unwilling or unable to provide informed consent.
结局指标
主要结局
Procedural time
时间窗: Procedure (At time of ablation)
Comparison of the procedural time (in minutes) between groups
次要结局
- Radiofrequency (RF) ablation time(Procedure (At time of ablation))
- First pass isolation rate(Procedure (At time of ablation))
- Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation(Months 4-6 after ablation)
- Fluoroscopy dose(Procedure (At time of ablation))
研究者
Prof. Dr. Mattias Duytschaever
Principal Investigator
AZ Sint-Jan AV
研究点 (5)
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