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临床试验/NCT07330791
NCT07330791已完成不适用

Right Phrenic Nerve Localization Using CT Scanning: Implications for Radiofrequency Ablation Procedures

Centro Medico Teknon1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
analyse the anatomy of the RPN

研究概览

简要总结

The anatomical location of the right phrenic nerve (RPN) in close proximity to the right pulmonary veins has become a critical consideration for electrophysiologists performing pulmonary vein isolation, the cornerstone treatment for atrial fibrillation. Although radiofrequency ablation in this region is rarely associated with complications-unlike cryoballoon ablation-the proximity of the RPN to the ablation site is considered the most widely accepted mechanism of nerve injury. Therefore, accurately defining its anatomical course is essential to prevent complications.

This concern extends to any ablation procedure performed near the RPN, including those targeting the lateral-posterior region of the right atrium, particularly during atrial tachycardia ablation or cardioneuroablation. Several methods have been used to precisely localize the RPN. The most commonly employed technique is phrenic nerve stimulation; however, there is growing interest in the use of computed tomography (CT) to identify structures running parallel to the nerve-such as the pericardiophrenic artery and vein-enhanced with contrast. Three-dimensional reconstruction through image segmentation has proven useful in defining the anatomy of cardiac chambers and adjacent extracardiac structures.

This study aims to compare two approaches for visualizing the course of the right phrenic nerve: one based on computed tomography imaging and the other on the nerve's response to stimulation during the procedure. This comparison will allow us to assess the concordance between imaging findings and intra-procedural observations, ultimately contributing to improved procedural safety.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to provide informed consent
  • Patients who have undergone or will undergo transcatheter AF ablation or CNA
  • Availability of 64-slice contrast-enhanced MDCT with RPN segmentation using ADAS® software prior to ablation
  • Age ≥ 18 years

排除标准

  • Inability to provide informed consent
  • Inability to perform contrast-enhanced CT before transcatheter AF ablation or CNA
  • Age < 18 years

研究组 & 干预措施

This study will enroll patients undergoing two distinct types of ablative procedures g

A total of 80 consecutive patients will be included:

  • 60 patients will be enrolled using a single electric stimulation output set at 20 mA, 2 ms amplitude width and 1000 ms cycle length
  • 20 patients will be enrolled using a double electric stimulation output set respectively at 10 mA and 20 mA (2 ms amplitude width and 1000 ms cycle length)

结局指标

主要结局

analyse the anatomy of the RPN

时间窗: From January 2021 to April 2025

The primary endpoint of this study is to analyse the anatomy of the RPN using three-dimensional (3D) imaging and iso-distance mapping with ADAS® software, and to validate its accuracy through traditional pace mapping.

Accuracy of Imaging-Guided Anatomical Localization of the Phrenic Nerve with ADAS® software Compared With Conventional Pacemapping

时间窗: from the procedure to 12 months later

The positions as observed by the 2 different methods are compared and the correlation was expressed as a percentage. Global image correlation is computed as the mean correlation between methods.

次要结局

未报告次要终点

研究者

发起方
Centro Medico Teknon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Berruezo, MD, PhD

Chief of Electrophysiology Unit

Centro Medico Teknon

研究点 (1)

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