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
This trial does not accept healthy volunteersQualifiers
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 population
Established asystolic reflex syncope
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Right atrial ablation
Procedure/SurgeryEligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to right atrial ablation. The patients receive a right atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator's decision. They are reported in the CRF.
Bi-atrial ablation
Procedure/SurgeryEligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to bi-atrial ablation. The patients receive a bi-atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator's decision. They are reported in the CRF.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Right atrial ablation group1 intervention
Group B: Bi-atrial ablation group1 intervention
Trial outcomes
Primary outcomes
1
Mounthly frequency of asystolic episodes >3 sec
Frequency of asystolic episodes \>3 sec per month detected through ILR monitoring before and after ablation.
Time frame
through study completion, an average of 1 year2
Freedom from ablation-related complications
Freedom from ablation-related complications and from pacemaker implantation during the follow-up period;
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Burden of syncopal episodes
Comparison betwen the mounthly burden of syncopal episodes before and after ablation;
Time frame
through study completion, an average of 1 year2
heart rate (HR) and heart rate variability (HRV)
Pattern of heart rate (HR) and heart rate variability (HRV) detected by ILR before andafter ablation.
Time frame
through study completion, an average of 1 year3
Time to first asystolic and syncope recurrence
Tme to first asystolic pause \>3 sec e and to first syncope recurrence
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov
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