Right Phrenic Nerve Localization on CT for Ablation
Right Phrenic Nerve Localization Using CT Scanning: Implications for Radiofrequency Ablation Procedures
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona
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Barcelona, Barcelona, Spain, 08022
- Antonio Berruezo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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This study will enroll patients undergoing two distinct types of ablative procedures g
A total of 80 consecutive patients will be included:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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analyse the anatomy of the RPN
Time Frame: From January 2021 to April 2025
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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.
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From January 2021 to April 2025
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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
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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.
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from the procedure to 12 months later
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Phrenic nerve CT-Localization
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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