CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Efficacy: Acute procedural success
研究概览
简要总结
In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).
详细描述
BACKGROUND: In a population of paroxysmal AF 'CLOSE'-guided PVI (Target Ablation index (AI) >550 and >400 for anterior and posterior wall respectively, interlesion distance ≤6mm) has been shown to obtain single-procedure durable PV isolation. However, the optimal RF power and stability criteria is unknown.
OBJECTIVES: With this study, we aim at evaluation the efficacy and the safety of higher power (45 watts) and stricter stability criteria (3 mm for 3 sec) as compared to a standard CLOSE protocol (35 watts with stability of 3 mm for 8 sec) in patients referred for a first ablation for paroxysmal AF.
POPULATION: Eligible patients are patients with paroxysmal AF who are planned for a 'CLOSE'-guided PV isolation for paroxysmal AF. At the time of the procedrual planning, we will ask the patient his/her consent for collectio of data. We aim at including 100 patients.
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
- •All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease
- •Signed Patient Informed Consent Form
- •Age 18 years or older
- •Able and willing to comply with all follow-up testing and requirements
排除标准
- •Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF)
- •Previous ablation for AF
- •LA antero-posterior diameter>50 mm (parasternal long axis view , PLAX)
- •LVEF <35% (ejection fraction)
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •CABG procedure within the last three months
- •Awaiting cardiac transplantation or other cardiac surgery
- •Documented left atrial thrombus on imaging
- •Diagnosed atrial myxoma
- •Women who are pregnant or breastfeeding
- •Acute illness or active systemic infection or sepsis
- •Unstable angina
- •Uncontrolled heart failure
- •Myocardial infarction within the previous two months
- •History of blood clotting or bleeding abnormalities
- •Contraindication to anticoagulation therapy (ie, heparin or warfarin)
- •Life expectancy less than 12 months
- •Enrollment in any other study evaluating another device or drug
- •Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
结局指标
主要结局
Efficacy: Acute procedural success
时间窗: At time of ablation
First pass pulmonary vein isolation confirmed after adenosine injection
Safety: Absence of clinical complications
时间窗: From time of ablation to 1 month post procedure
Absence of clinical complications during the procedure and up to one month thereafter
次要结局
- Duration for pulmonary vein isolation(At time of ablation)
- Fluoroscopic duration and irradiation (AK)(At time of ablation)
- Amount of ablation points associated with temperature rise(At time of ablation)
- Procedural duration time(At time of ablation)
- Number of ablation points with an oesophageal temperature rise >39°C(At time of ablation)
- Number of dislocations(At time of ablation)
- Maximum temperature in case of oesophageal temperature rise(At time of ablation)
- Longterm procedural success rate(Six months after ablation)
- Maximum temperature in case of temperature rise(At time of ablation)
- Incidence of adverse events related to ablation(From time of ablation to 6 months post procedure)
- Reconnection rate after adenosine(At time of ablation)
- First pass encirclement isolation rate(At time of ablation)
研究者
Sebastien Knecht
Professor Doctor
AZ Sint-Jan AV