Actively Recruiting
Cardioneuroablation and Ventricular Proarrhythmia
Led by Centre of Postgraduate Medical Education · Updated on 2025-05-14
50
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cardioneuroablation and Ventricular Proarrhythmia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe, recurrent symptoms due to reflex syncope with ECG documented asystole longer than 3 seconds
- History of ineffective prior non-pharmacological treatment
- Positive baseline atropine test (sinus rate acceleration over 30% and no atrio-ventricular block after 2 mg intravenous atropine)
- Informed written consent to participate in the study
You will not qualify if you...
- Lack of consent to participate in the study
- Contraindications to perform right ventricular stimulation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Poland, 04-073
Actively Recruiting
Research Team
P
Piotr Kulakowski, MD PhD
CONTACT
A
Agnieszka Sikorska, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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