Implantable Loop Recorder and Cardioneuroblation (ILR-CNA)

Istituto Auxologico Italiano

Status

Not yet enrolling

Conditions

Reflex Syncope

Treatments

Procedure: Bi-atrial ablation

Procedure: Right atrial ablation

Study type

Observational

Funder types

Other

Identifiers

NCT07162740

ILR-CNA

Details and patient eligibility

About

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

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 18 years old

Volunteers

No Healthy Volunteers

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