Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Computed Tomography

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorCentre of Postgraduate Medical Education

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Cardioneuroablation

    Procedure/Surgery

    Endocardial radio-frequency ablation of areas of ganglionated plexi in the left and the right atrium

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Predictive value of fragmented atrial potentials

Sensitivity, specificity, positive and negative predictive value of fragmented atrial potentials for the acute efficacy of cardioneuroablation

Time frame
During procedure (2 hours)

Secondary outcomes

1

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

Time frame
During procedure (2 hours)
2

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

Time frame
During procedure (2 hours)
3

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

Time frame
During procedure (2 hours)
4

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

Time frame
During procedure (2 hours)

Other outcomes

Sponsors and contacts

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