Comparative Evaluation of the Efficacy and Safety of High-Power Short-Duration Radiofrequency Ablation and Standard Low-Power Ablation in Catheter Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Recurrence of AF
研究概览
简要总结
Atrial fibrillation (AF) is the most common cardiac arrhythmia and represents one of the leading causes of cardiovascular morbidity and mortality. According to current data, AF is associated with approximately 20% of all ischemic strokes, while the risk of stroke in patients with this arrhythmia is increased fivefold. Ischemic stroke in patients with AF is characterized by a more severe clinical course, more frequently results in death, is associated with significant disability, and carries a higher risk of recurrence compared with strokes of other etiologies. Consequently, the risk of death in patients with AF-associated stroke is doubled, while the economic costs of treatment increase by an average of 1.5 times.
The aim of the present study is to perform a comparative evaluation of the efficacy of two interventional treatment strategies for atrial fibrillation: very high-power short-duration radiofrequency ablation (90 W) and conventional low-power radiofrequency ablation (35-45 W) for pulmonary vein isolation using the "CLOSE protocol" approach with a non-fluoroscopic navigation system. The efficacy of the interventions will be assessed both in the early postoperative period and during long-term follow-up over 12 months.
详细描述
The study is designed to involve highly specialized centers with substantial clinical experience in the interventional treatment of atrial fibrillation (at least 300 procedures annually) and equipment enabling both conventional low-power radiofrequency ablation (35-45 W) and very high-power short-duration ablation (vHPSD) using the QMODE Plus mode (90 W) for pulmonary vein isolation performed according to the "CLOSE protocol" strategy with non-fluoroscopic navigation systems. The study population will include patients with paroxysmal and persistent forms of atrial fibrillation.
This randomized open-label controlled trial will be conducted with allocation of patients into two groups according to the interventional treatment strategy applied. In the first group, pulmonary vein isolation will be performed using conventional low-power settings (35-45 W), whereas in the second group, pulmonary vein isolation will be carried out using very high-power short-duration ablation (vHPSD) with 90 W energy delivery. Patient randomization will be performed using the sealed-envelope method with a restricted block randomization scheme (block size of 10 patients, with equal allocation of 5 patients to each group). The study is expected to be completed after enrollment of 196 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old;
- •Atrial fibrillation resistant to antiarrhythmic therapy;
- •Paroxysmal form of atrial fibrillation;
- •Persistent form of atrial fibrillation;
- •The patient's consent to participate in the study.
排除标准
- •Exclusion Criteria:
- •Age under 18 and over 80 years old;
- •The presence of another cardiac pathology requiring surgical treatment;
- •Congenital heart defects;
- •Previous "open" cardiac surgery;
- •Bone marrow diseases;
- •Pathology of the blood coagulation system;
- •The left ventricular ejection fraction is less than 40%;
- •Moderate to severe renal insufficiency (creatinine clearance <50 ml/min);
- •Drug-resistant hypertension (despite hypotensive therapy);
- •Organically altered mitral valve;
- •There are reasons to assume that the patient will not show up for subsequent visits (control points of the study) for various reasons;
- •The patient's participation in another clinical trial.
结局指标
主要结局
Recurrence of AF
时间窗: From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 12 months
The number of patients with recurrent atrial fibrillation after surgery
次要结局
- Hospital mortality(From the date of ablation until the date of death, assessed up to 5 days)
- Non-lethal events(From the date of ablation to the date of any of the listed events, assessed up to 5 days)
- Long-term mortality(From the date of ablation until the date of death, assessed up to 12 months)
- Cerebral events(From the date of ablation until the date of the event, assessed up to 12 months)