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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
RECRUITING
Warsaw
Contact Information
Primary
Piotr Kułakowski, MD PhD
kulak@kkcmkp.pl
+48 22 5152757
Backup
Agnieszka Sikorska, MD PhD
sikorska.agnieszka.anna@gmail.com
+48 22 5152757
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Sponsors
Leads: Centre of Postgraduate Medical Education

This content was sourced from clinicaltrials.gov