Implantable Loop Recorder and Cardioneuroblation
ConditionReflex Syncope
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-18
SponsorIstituto Auxologico Italiano
About this trial
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 atrium, others in both atria (biatrial). There are no comparative studies between the two procedures
Eligibility criteria
Qualifiers
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).
Disqualifiers
Intrinsic sinus dysfunction or atrioventricular node disease.
Constitutional hypotension and orthostatic intolerance syndromes
Overt structural heart disease
Alternative diagnoses of syncope
Trial design
Treatments tested in this trial
- Right atrial ablation
- Bi-atrial ablation
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov