Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.
Age ≥ 18 years and
Undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and
Presence of at least one of the following conduction disorders and
Pre-procedural basal conduction disorder (e.g., right/left bundle branch block, bifascicular block, IVCD) with QRS between 120-160 msec.
Immediate indication for permanent pacemaker following the procedure.
Persistent complete atrioventricular block.
QRS >160 msec and/or PR prolongation.
Haemodynamic instability or complications of TAVI (major bleeding, stroke, decompensated heart failure) that contraindicate early discharge.
Parallel
Standard care
BehavioralPatients discharged according to standard care
PhysioMem PM 100 4G ambulatory monitoring system
DevicePatients discharged with PhysioMem PM 100 4G ambulatory monitoring system
Composite of all-cause death and rehospitalization for any reason
Proportion of patients with: * All cause of death * Rehospitalization for any reason
Clinically relevant arrhythmic event requiring a change in therapy
Proportion of patients with clinically relevant arrhythmic event requiring a change in therapy, defined as the occurrence of any of the following: * Cardiac conduction disorders * Clinically relevant tachyarrhythmias
All-cause death
Incidence of all-cause death
All-cause death
Incidence of all-cause death
Unscheduled hospital readmission for any reason
Incidence of unscheduled hospital readmission for any reason
Unscheduled hospital readmission for any reason
Incidence of unscheduled hospital readmission for any reason
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