Evaluation of the Non-invasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorder Through TAVI Implantation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute

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

Treatment groups

100 Participants
are divided into 2 treatment groups