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

Summary

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

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.

Conditions3

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