Potential consequences of cardioneuroablation for vasovagal syncope: A call for appropriately designed, sham-controlled clinical trials.
Praloy Chakraborty, Peng-Sheng Chen, Michael H Gollob...
https://pubmed.ncbi.nlm.nih.gov/38104955Actively Recruiting
Led by Centre of Postgraduate Medical Education · Updated on 2025-05-14
50
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effects of cardioneuroablation (CNA) on the heart's electrical activity and vulnerability to dangerous ventricular arrhythmias in patients with reflex syncope that causes asystole. Reflex syncope is a condition where vagal nerve activity causes sudden heart pauses. CNA aims to reduce this by ablating parts of the parasympathetic nervous system affecting the heart. However, reducing parasympathetic protection may increase risk of ventricular arrhythmias, and this study seeks to understand these acute effects. The study involves 50 patients undergoing CNA, a procedure performed under general anesthesia using a radiofrequency catheter to ablate ganglionated plexi in the heart. The procedure targets parasympathetic nerve endings mainly in the atria but may affect ventricular nerves as well. During and after CNA, researchers will measure heart electrical parameters including QTc interval, QT dispersion, right ventricular action potential duration, and refractory periods. They will also assess susceptibility to ventricular arrhythmias using programmed ventricular stimulation before and after CNA, as well as after administering atropine and isoproterenol. Participants will be monitored closely during the procedure with ECG and invasive electrophysiology measurements. These include measuring heart rate changes, ventricular action potentials, and arrhythmia vulnerability. Follow-up includes ECG assessments one day before and after CNA. The main outcome is the inducibility of ventricular arrhythmias within two hours after CNA. Secondary outcomes include changes in QT intervals and ventricular electrical properties. The study will help clarify the safety and acute impact of CNA on ventricular arrhythmias in patients with reflex syncope.
CONDITIONS
Cardioneuroablation and Ventricular Proarrhythmia
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day procedure with assessments lasting approximately 2 hours
Participants undergo cardioneuroablation, a procedure involving radiofrequency ablation of heart ganglionated plexi to treat reflex syncope. The procedure includes electrophysiological measurements before and after ablation to assess effects on ventricular arrhythmias and heart electrical activity.
1 in-person procedure visit with continuous monitoring and assessments
Total: 1 location
1
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Poland, 04-073
Actively Recruiting
P
Piotr Kulakowski, MD PhD
A
Agnieszka Sikorska, MD PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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