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临床试验/NCT04447300
NCT04447300Unknown不适用

Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.

Assiut University0 个研究点目标入组 50 人开始时间: 2021年9月20日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Abdelrady Abdelsalam Farghaly

Assistant lecturer of cardiovascular medicine

Assiut University

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