NCT07162740

Implantable Loop Recorder and Cardioneuroblation

Comparative Study of Right Atrial Versus Bi-atrial Cardioneuroablation of Asystolic Reflex Syncope Verified by Implantable Loop Recorder

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to determine which method of vagal ganglia ablation is most effective in preventing recurrences of reflex asystole syncope. Currently, some centers perform ablation only in the right atrium, others in both atria (biatrial). There are no comparative studies between the two procedures

Detailed description

Cardioneuroablation (CNA) therapy for reflex asystole syncope is becoming increasingly popular. The best method of CNA is debated, with no studies comparing the syncopal recurrence rates of right atrium ablation versus bi-atrial ablation. Evaluating the clinical efficacy of CNA is challenging due to symptom variability, intermittent presentation, complex pathophysiology, and different treatment options. The difficulty of obtaining precise follow-up data in patients with intermittent symptoms is well known. With ILR, more objective tracking can be achieved. The aim of the study is to verify the efficacy of CNA on the reduction of the asystole reflex documented by continuous monitoring by ILR in patients undergoing right atrial ablation compared to bi-atrial ablation

Conditions

• Reflex Syncope

Interventions

Type	Name	Description
PROCEDURE	Right atrial ablation	Eligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to right atrial ablation. The patients receive a right atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator's decision. They are reported in the CRF.
PROCEDURE	Bi-atrial ablation	Eligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to bi-atrial ablation. The patients receive a bi-atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator's decision. They are reported in the CRF.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: Italy