Implantable Loop Recorder and Cardioneuroblation

Not yet recruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 1, 2027

Study Completion Date

October 1, 2027

Conditions
Reflex Syncope
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

20149

IRCCS Istituto Auxologico Italiano, Milan

All Listed Sponsors
lead

Istituto Auxologico Italiano

OTHER

NCT07162740 - Implantable Loop Recorder and Cardioneuroblation | Biotech Hunter | Biotech Hunter