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Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients

Italy24 participantsStarted 2022-09-20

Plain-language 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).

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Intrapatient incidence of asystolic episodes before and after cardioneuroablation

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05751330

SponsorPoliclinico Casilino ASL RMB

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-20

Contact for this trial

Marco Rebecchi, MD

+393402873746 marcorebecchi3@virgilio.it