Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)

Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)

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.

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.

Inclusion Criteria:

All inclusion criteria must be met

• 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.
• De novo conduction disorder after TAVI (de novo bundle branch block) with QRS between 120-160 msec.
• Clinical stability at 24 hours post-procedure and
• Capacity to give informed consent.

Exclusion Criteria:

No exclusion criteria must be met

• 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.
• Technical or clinical impossibility of using the PhysioMem PM 1004G monitoring system.
• Life expectancy < 12 months due to non-cardiovascular comorbidity.
• Refusal or inability to undergo outpatient follow-up.
• Pregnant or breastfeeding.