Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients

Not Applicable

Recruiting

• Conditions: Neurally Mediated Syncope
• Interventions: Procedure: Transcatheter ablation of cardiac ganglionated plexi

• Registration Number: NCT05751330
• Lead Sponsor: Policlinico Casilino ASL RMB

Brief Summary

Multicenter Italian interventional "proof of efficacy" clinical trial that aims to evaluate the incidence of asystolic pauses and heart rate in patients with CNS who performed severe CNA identified through asystolic pauses identification by implantable loop recorder. The study is independent, "investigator-initiated," sponsored by a nonprofit scientific association called the Italian Multidisciplinary Group for the Study of Syncope (GIMSI).

Detailed Description

The so called "Cardioneuroablation (CNA)" focused on the endocardial ablation of atrial ganglionated plexi has proven to be efficacy in patients affected by neuro-mediated cardioinhibitory syncope (NCS). No center currently has sufficient case series to establish long-term efficacy and safety results, for which a multicenter interventional study is therefore needed.

The aim of the study will be to evaluate the efficacy and safety of CNA focused in NCS patients. The ablation procedure, consists of radiofrequency delivering at right atrial anatomic sites where the underlying presence of GP clusters is regarded as highly probable: 1) the inferior-posterior area (first ablation site): inferior right GP placed between inferior vena cava, coronary sinus ostium and near the atrio-ventricular groove, 2) the superior-posterior area (second ablation site): superior right atrial GP, adjacent to the junction of the superior vena cava and the posterior surface of RA.

Study Timeline

• Study Start: 2022-09-20
• Study First Submitted: 2023-01-04
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02
• Primary Completion: 2024-09-20
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age between 18 and 60 years
• Patients with a clinical diagnosis of neuromediated syncope according to class I criteria of the ESC guidelines, Table 1
• Clinical history of recurrent syncope (≥2 in the last year or ≥3 in the last 2 years), severe, not tolerated by the patient
• Documentation of ≥2 asystolic pauses >3 sec daytime on ECG monitoring by implantable loop recorder (ILR), with or without syncope
• Refusal by patient to perform pacemaker implantation

Tilt test is recommended but not mandatory. Patients with negative tilt test are also enrollable. It can be either positive or negative.

Exclusion Criteria

• Absence of sinus dysfunction and atrioventricular node disease.
• Absence of structural heart disease
• Possible alternative diagnoses of syncope

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients affected by Cardioinhibitory Neurocardiogenic Syncope	Transcatheter ablation of cardiac ganglionated plexi	-

Primary Outcome Measures

Name	Time	Method
Intrapatient incidence of asystolic episodes before and after cardioneuroablation	through study completion, an average of 1 year	frequency (number and percentage) of asystolic episodes before and after ablation

Secondary Outcome Measures

Name	Time	Method
Comparison of mean heart rate, before and after cardioneuroablation, incidence of (pre)syncopal episodes before and after CNA and, finally, beat-to beat HR variability during ILR monitoring	through study completion, an average of 1 year	intrapatient comparison of mean heart rate (bpm), beat-to-beat variability of heart rate, before and after CNA.

Trial Locations

Locations (1)

Policlinico Casilino; 🇮🇹 Rome, Lazio, Italy