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Cardioneuroablation: Comparison of Right Versus Left Atrial Approach in Patients With Reflex Syncope

NCT05225532 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-14

No results posted yet for this study

Summary

Introduction. Reflex vaso-vagal syncope (VVS) is the most frequent cause of transient loss of consciousness and it's treatment remains a challenge. Cardioneuroablation (CNA) is a relatively new and promising method, however, the optimal technique for performing CNA has not been established.

Aim. To compare effectiveness of CNA performed in the right atrium (RA) versus left atrium (LA) in achieving total vagal denervation and in preventing syncope recurrences.

Methods. Study group. Consecutive patients with recurrent cardioinhibitory or mixed VVS, undergoing CNA between January 2022 and February 2024 will be randomized to the RA or LA groups.

CNA is performed under general anesthesia with muscle relaxation using a 3.5 mm irrigated tip contact force catheter and ablation index.The whole procedure is performed under intracardiac echocardiography (ICE) guidance. Efficacy of vagal denervation is assessed using extracardiac vagal stimulation (ECVS). Before starting RF delivery baseline electrophysiological parameters are measured. Next, baseline ECVS from the left and right jugular veins is performed.

In the LA group, after gaining transseptal access under ICE guidance, an electroanatomical map of the LA is created and anatomically-based ablation of GP from the LA is performed. Firstly, septal GP are ablated and if total vagal denervation is not achieved, GP located close to left pulmonary veins are ablated. If ECVS still shows vagal response, additional RF applications are delivered in the RA. Then, final ECVS is performed and procedure is finished.

In the RA group, GP located in this chamber are ablated and if ECVS shows persistent vagal response, transseptal puncture is performed and ablation in the LA is performed. Afterwards, final ECVS is performed.

Duration of follow-up is two years. Patients will attend check-up visits at 3, 12 and 24 months with standard ECG, 24hr ambulatory ECG and QoL assessment.

Primary endpoint is complete vagal denervation measured by ECVS (no sinus arrest and no AVB after CNA) using LA approach only versus RA approach only Secondary endpoints include final ECVS results and follow-up data - syncope/presyncope recurrences and QoL.

Conditions

  • Reflex Syncope

Interventions

OTHER

Radiofrequency ablation

Radiofrequency ablation of ganglionated plexi located in the left or right atrium

Sponsors & Collaborators

  • Centre of Postgraduate Medical Education

    lead OTHER

Principal Investigators

  • Piotr Kulakowski, MD PhD · Postgraduate Centre for Medical Eductaion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05225532 on ClinicalTrials.gov