UnknownNot Applicable

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 range

18 Years – 60 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Neurally Mediated Syncope trials