About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Standard care
- PhysioMem PM 100 4G ambulatory monitoring system