Reflex Syncope
Conditions
Keywords
Syncope, reflex syncope, implantable loop recorder, Vagal ganglia ablation, Cardioneuroablation, Asystole
Brief 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
Interventions
PROCEDURERight 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.
PROCEDUREBi-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.
Sponsors
Istituto Auxologico Italiano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burden of syncopal episodes | through study completion, an average of 1 year | Comparison betwen the mounthly burden of syncopal episodes before and after ablation; |
| heart rate (HR) and heart rate variability (HRV) | through study completion, an average of 1 year | Pattern of heart rate (HR) and heart rate variability (HRV) detected by ILR before andafter ablation. |
| Time to first asystolic and syncope recurrence | through study completion, an average of 1 year | Tme to first asystolic pause \>3 sec e and to first syncope recurrence |
Countries
Italy
Contacts
Primary ContactMichele Brignole, Cardiologist
Backup ContactLuca Grappiolo
Outcome results
None listed