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Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Computed Tomography

RecruitingNAAges 14 Years - anyAllCentre of Postgraduate Medical Education
NCT06472102 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * contraindications to perform cardioneuroablation * contraindications to perform computed tomography with intravenous contrast injection * lack of informed written consent obtained
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What it tests

  • Cardioneuroablation
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Where

1 site
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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