Clinical Trial

Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Computed Tomography

Study acronym: Roman5
Recruiting
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Record status
This record was last updated September 26, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Cardioneuroablation (CNA) is a new method for the treatment of asystolic reflex syncope, however, optimal methods for identification of presumed sites of ganglionated plexi (GP), which are the target for CNA and are located in the epicardial fat, have not yet been established. This study will compare the accuracy of three methods used for identification of these areas: intracardiac recordings of fractionated atrial electrograms, intracardiac echocardiography and computed tomography. The study group will consist of 100 patients undergoing CNA in our institution. The procedure will be performed in a standard manner with the use of extracardiac vagal stimulation as the intraprocedural end-point. Correlation between the three methods used for localisation of optimal sites for CNA as well as their predictive value for achieving effective CNA will be computed.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-06-22.
Trial Details
NCT Number NCT06472102
Lead Sponsor Centre of Postgraduate Medical Education
Conditions Syncope, Vasovagal
Enrollment 100 participants
Start Date 2024-05-20
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-26