Acute electRophysiOlogical Changes of Ventricular Myocardium Following 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 promising tool to treat patients with asystolic reflex syncope. CNA acts through complete or near complete abolition of vagal nerve chronotropic and dromotropic effects on the heart, resulting in sinus node acceleration and improved atrio-ventricular conduction, which in turn prevents vagally-mediated reflex asystole. However, lack of parasympathetic protection may potentially be proarrhythmic, especially on the ventricular level. Whether this is a real threat is not known. Therefore, the aim of our study is to assess acute effects of CNA-induced total vagal denervation, measured by extracardiac vagal stimulation, on ECG and electrophysiological parameters as well as vulnerability to ventricular arrhythmias. The study group will consist of 50 consecutive patients undergoing CNA in our institution. Cardioneuroablation will be performed in standard manner. The following parameters will be assessed at baseline and after CNA (directly after CNA, after atropine injected after CNA and after isoproterenol bolus injected at the very end of the procedure): QTc interval, QT dispersion, right ventricular action potential duration, right ventricular effective refractory period and susceptibility to complex ventricular arrhythmias using programmed ventricular stimulation.

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

• history of ineffective prior non-pharmacological treatment

• positive baseline atropine test (sinus rate acceleration \> 30% and no atrio-ventricular block following 2 mg of intravenous atropine)

• informed written consent to participate in the study

Locations
Other Locations
Poland
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
RECRUITING
Warsaw
Contact Information
Primary
Piotr Kulakowski, 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: 50
Sponsors
Leads: Centre of Postgraduate Medical Education

This content was sourced from clinicaltrials.gov