RecruitingNot ApplicableNCT06472102

Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Computed Tomography

Value of fRagmented Atrial electrOgrams, Computed Tomography and Intracardiac Echocardiography for Identification of optiMal Sites for Radio-frequency Delivery During cArdioneuroablation for Asystolic Reflex syNcope


Sponsor

Centre of Postgraduate Medical Education

Enrollment

100 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 Years

Inclusion Criteria3

  • 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

Exclusion Criteria3

  • contraindications to perform cardioneuroablation
  • contraindications to perform computed tomography with intravenous contrast injection
  • lack of informed written consent obtained

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Interventions

PROCEDURECardioneuroablation

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


Locations(1)

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, Masovian Voivodeship, Poland

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NCT06472102


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