Status:
NOT_YET_RECRUITING
Implantable Loop Recorder and Cardioneuroblation
Lead Sponsor:
Istituto Auxologico Italiano
Conditions:
Reflex Syncope
Eligibility:
All Genders
18-18 years
Brief Summary
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 at...
Detailed 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 atri...
Eligibility Criteria
Inclusion
- 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
- Intrinsic sinus dysfunction or atrioventricular node disease.
- Constitutional hypotension and orthostatic intolerance syndromes
- Overt structural heart disease
- Alternative diagnoses of syncope
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07162740
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 9 2025
Active Locations (1)
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1
IRCCS Istituto Auxologico Italiano
Milan, Italy, 20149