Clinical trial NCT05751330: Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients
Official title: Efficacy of Transcatheter Ablation of Ganglionic Plexuses (Cardioneuroablation) in Right Atrium in Patients With Asystolic Neuromediated Syncope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurally Mediated Syncope
Lead sponsor: Policlinico Casilino ASL RMB
Sponsor class: OTHER
Collaborators: name: Gruppo Italiano Multidisciplinare per lo Studio della Sincope
First posted: 2023-03-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intrapatient incidence of asystolic episodes before and after cardioneuroablation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: 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
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Casilino
state: Lazio
city: Rome
country: Italy
facility: Policlinico Casilino
state: Lazio
Study officials:
References:
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