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OpenTrials
Completed

NCT Number: NCT07330791

Right Phrenic Nerve Localization on CT for Ablation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antonio Berruezo

Barcelona, 08022, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. analyse the anatomy of the RPN

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centro Medico Teknon

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.