About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
severe, recurrent symptoms due to reflex syncope with ECG documented asystole >3 seconds, especially if associated with injury, or recurrent presyncope with persistent reflex bradycardia
history of ineffective prior non-pharmacological treatment and positive baseline atropine test (sinus rate acceleration > 30% and no AV block following 2 mg of intravenous atropine) -
informed written consent obtained
Disqualifiers
contraindications to perform cardioneuroablation
contraindications to perform computed tomography with intravenous contrast injection
lack of informed written consent obtained
Trial design
Single group
Treatments tested in this trial
Cardioneuroablation
Procedure/SurgeryEndocardial radio-frequency ablation of areas of ganglionated plexi in the left and the right atrium
Treatment groups
Trial outcomes
Primary outcomes
Predictive value of fragmented atrial potentials
Sensitivity, specificity, positive and negative predictive value of fragmented atrial potentials for the acute efficacy of cardioneuroablation
Secondary outcomes
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
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
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
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
Sponsors and contacts
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