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Implantable Loop Recorder and Cardioneuroblation
Sponsor: Istituto Auxologico Italiano
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 atrium, others in both atria (biatrial). There are no comparative studies between the two procedures
Official title: Comparative Study of Right Atrial Versus Bi-atrial Cardioneuroablation of Asystolic Reflex Syncope Verified by Implantable Loop Recorder
Key Details
Gender
All
Age Range
18 Years - 18 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2025-10-01
Completion Date
2027-10-01
Last Updated
2025-09-09
Healthy Volunteers
No
Conditions
Interventions
Right atrial ablation
Eligible 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
Eligible 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.
Locations (1)
IRCCS Istituto Auxologico Italiano
Milan, Italy