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Clinical Trials in Italy / NCT07162740
Starting soon Observational

Implantable Loop Recorder and Cardioneuroblation

NCT07162740 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Auxologico Italiano
Phase
Observational
Started
2025-10-01
Last updated
2025-09-09

Condition(s) studied

Reflex Syncope

Investigational drug(s) / intervention(s)

Right atrial ablationBi-atrial ablation

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.

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mounthly frequency of asystolic episodes >3 sec — through study completion, an average of 1 year
    Frequency of asystolic episodes \>3 sec per month detected through ILR monitoring before and after ablation.
  • Freedom from ablation-related complications — through study completion, an average of 1 year
    Freedom from ablation-related complications and from pacemaker implantation during the follow-up period;

Trial sites (1)

FacilityCityRegionStatus
IRCCS Istituto Auxologico Italiano Milan Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07162740 on ClinicalTrials.gov ↗ ← All trials in Italy