Implantable Loop Recorder and Cardioneuroblation

Not yet recruiting

• Conditions: Reflex Syncope

• Registration Number: NCT07162740
• Lead Sponsor: Istituto Auxologico Italiano

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

Study Timeline

• Study First Submitted: 2025-08-01
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2025-10-01
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Burden of syncopal episodes	through study completion, an average of 1 year	Comparison betwen the mounthly burden of syncopal episodes before and after 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

Trial Locations

Locations (1)

IRCCS Istituto Auxologico Italiano; 🇮🇹 Milan, Italy