An observational study in Reflex Syncope, sponsored by Istituto Auxologico Italiano. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Istituto Auxologico Italiano · Observational
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
88 studies on the registry are indexed under Syncope, Vasovagal; 28 are open to participants now.
This study's planned enrollment of 50 is below the median of 140 across 29 observational studies indexed under Syncope, Vasovagal.
Browse Syncope, Vasovagal studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Established asystolic reflex syncope
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Right atrial ablation
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 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.
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.
Mounthly frequency of asystolic episodes >3 sec
Frequency of asystolic episodes \>3 sec per month detected through ILR monitoring before and after ablation.
Time frame: through study completion, an average of 1 year
Freedom from ablation-related complications
Freedom from ablation-related complications and from pacemaker implantation during the follow-up period;
Time frame: through study completion, an average of 1 year
Burden of syncopal episodes
Comparison betwen the mounthly burden of syncopal episodes before and after ablation;
Time frame: through study completion, an average of 1 year
heart rate (HR) and heart rate variability (HRV)
Pattern of heart rate (HR) and heart rate variability (HRV) detected by ILR before andafter ablation.
Time frame: through study completion, an average of 1 year
Time to first asystolic and syncope recurrence
Tme to first asystolic pause \>3 sec e and to first syncope recurrence
Time frame: through study completion, an average of 1 year
Plan to share: Yes — After 6 months from the publication of the study upon reasonable request
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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