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Clinical Trials in Spain / NCT07456280
Recruiting Not applicable

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

NCT07456280 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Phase
Not applicable
Started
2026-07-20
Last updated
2026-07-22

Condition(s) studied

Severe Aortic Valve StenosisCardiovascular Diseases

Investigational drug(s) / intervention(s)

Standard carePhysioMem PM 100 4G ambulatory monitoring system

Standard care: Patients discharged according to standard care

PhysioMem PM 100 4G ambulatory monitoring system: Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Composite of all-cause death and rehospitalization for any reason — 30 days
    Proportion of patients with: * All cause of death * Rehospitalization for any reason
  • Clinically relevant arrhythmic event requiring a change in therapy — 30 days
    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

Trial sites (1)

FacilityCityRegionStatus
Hospital Unniversitari Vall d'Hebron Barcelona Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07456280 on ClinicalTrials.gov ↗ ← All trials in Spain