Implantable Loop Recorder and Cardioneuroblation

N/ANot Yet RecruitingNCT07162740

Istituto Auxologico Italiano50 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Reflex Syncope

Interventions

Right atrial ablationPROCEDURE

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.

Bi-atrial ablationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 60 years * Clinical diagnosis of reflex syncope as per class I criteria of the ESC guidelines * History of recurrent severe syncopes (≥2 in the last year or ≥3 in the last 2 years), significantly affecting the quality of life, nonresponding to lifestyle measures. * Documentation by means of prolonged ECG monitoring of an asystolic pause \>6 sec or of an asystolic syncope \>3 sec and/or an asystolic syncope induced during tilt testing (Vasis 2B form). Exclusion Criteria: * Intrinsic sinus dysfunction or atrioventricular node disease. * Constitutional hypotension and orthostatic intolerance syndromes * Overt structural heart disease * Alternative diagnoses of syncope * Pregnancy or breastfeeding

Locations (1)

IRCCS Istituto Auxologico Italiano

Milan, Italy

Outcomes

Primary Outcomes

Mounthly frequency of asystolic episodes >3 sec

Frequency of asystolic episodes \>3 sec per month detected through ILR monitoring before and after ablation.