Actively Recruiting

Phase Not Applicable
Age: 14Years +
All Genders
ID06458140

Acute Electrophysiological Changes of Ventricular Myocardium Following Cardioneuroablation for Asystolic Reflex Syncope

Led by Centre of Postgraduate Medical Education · Updated on 2025-05-14

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Cardioneuroablation and Ventricular Proarrhythmia

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

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 showing sinus rate increase greater than 30% and no atrio-ventricular block after 2 mg intravenous atropine
  • Provided informed written consent to participate in the study
Not Eligible

You will not qualify if you...

  • Lack of consent to participate in the study
  • Contraindications to performing right ventricular stimulation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

Trial Site Locations

Total: 1 location

1

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, Poland, 04-073

Actively Recruiting

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Research Team

P

Piotr Kulakowski, MD PhD

A

Agnieszka Sikorska, MD PhD

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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Published Research Related To This Trial

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/38104955

"Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation.

Jose C Pachon, Enrique I Pachon, Juan C Pachon...

https://pubmed.ncbi.nlm.nih.gov/15670960

Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial.

Roman Piotrowski, Jakub Baran, Agnieszka Sikorska...

https://pubmed.ncbi.nlm.nih.gov/36114133