Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Computed Tomography
NCT Number: NCT06472102
Acronym: Roman5
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Syncope, Vasovagal
Interventions: PROCEDURE: Cardioneuroablation
Sponsor: Centre of Postgraduate Medical Education
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-20
Completion Date: 2025-12-31
Locations: Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Mazowieckie, 04-073, Poland

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.

Primary Outcome Measures: Predictive value of fragmented atrial potentials, Sensitivity, specificity, positive and negative predictive value of fragmented atrial potentials for the acute efficacy of cardioneuroablation, During procedure (2 hours)
Secondary Outcome Measures: Localization of presumed areas of ganglionated plexi, To compare the localization of presumed areas of ganglionated plexi using fragmented atrial potentials recordings, intracardiac echocardiography and computed tomography, During procedure (2 hours)|Accuracy of identification of sites where effective cardioneuroablation was performed, Three methods used for identification of optimal sites for cardioneuroablation (fragmented atrial potentials, intracardiac echocardiography and computed tomography) will be compared regarding cardioneuroablation acute efficacy measured by extracardiac vagal stimulation, During procedure (2 hours)|Number of deflections of fragmented atrial potentials at inferior and superior areas of ganglionated plexi, Comparison of number of deflections between fragmented atrial potentials recorded at the areas of inferior and superior ganglionated plexi, During procedure (2 hours)|Duration of fragmented atrial potentials at inferior and superior areas of ganglionated plexi, Comparison of duration (in milliseconds) of fragmented potentials between fragmented atrial potentials recorded at the areas of inferior and superior ganglionated plexi, During procedure (2 hours)|Amplitude of fragmented atrial potentials at inferior and superior areas of ganglionated plexi, Comparison of amplitude (in millivolts) of fragmented potentials between fragmented atrial potentials recorded at the areas of inferior and superior ganglionated plexi, During procedure (2 hours)