Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Ablation success at 6-month after the index procedure
研究概览
简要总结
Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines [3].
Previous studies have shown that elimination of the negative component of the unipolar electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The persistence of such a negative component consistently corresponds to non-trans mural lesions [4].
详细描述
Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines [3].
Previous studies have shown that elimination of the negative component of the unipolar electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The persistence of such a negative component consistently corresponds to non-trans mural lesions [4].
The high-power short duration (HPSD) RF application applies to all RF energies delivered at more than 40 W [5]. Higher the power more is the resistive heating causing wider tissue injury [5]. The lesion size with HPSD is larger in width but lesser in depth compared to lower powers with longer duration [5]. In contrast, RF applications of lower power and longer duration result in larger dissipation of RF energies deep into the tissues due to conductive heating causing tissue destruction at greater depths [6]. Hence, there is a risk of collateral tissue damage [5].
HPSD ablation has been advocated as a means to minimize the risk of collateral organ damage as the lesions are smaller in depth. However, Maintaining a high power for a constant duration in the absence of a guide may not be the right strategy [5].
Unipolar waveform modification by complete elimination of the negative component may serve as a guide for HPSD ablation [5].
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal atrial fibrillation
排除标准
- •Age< 18 or > 80 years old,
- •Atrium (LA) diameter > 50 mm,
- •The presence of a mechanical mitral valve prosthesis,
- •Left ventricular ejection fraction < 40%,
- •Abnormal thyroid function,
- •Contraindication to anticoagulant therapy,
- •Current malignancy,
- •Prior catheter or surgical AF ablation.
结局指标
主要结局
Ablation success at 6-month after the index procedure
时间窗: 6 months
Ablation success is defined as no recurrence with no anti-arrhythmic drugs by taking history of symptoms from the patient and by Holter 48 Hours.
次要结局
未报告次要终点
研究者
Ahmad Abdelrady Abdelsalam Farghaly
Assistant lecturer of cardiovascular medicine
Assiut University
