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

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT07456280
Status
Recruiting
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Conditions

  • Cardiovascular Diseases
  • Severe Aortic Valve Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard care — BEHAVIORAL
    Patients discharged according to standard care
  • PhysioMem PM 100 4G ambulatory monitoring system — DEVICE
    Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system

Study Details

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.

Key Dates

First listed
Mar 6, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Jul 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Early discharge (24 hours post-TAVI)
    Patients will be discharged from the hospital 24 hours post-TAVI with PhysioMem PM 100 4G ambulatory monitoring system.
  • Active Comparator: Discharge according Standard Care
    Patients will be discharged from the hospital according standard care

Primary Outcome Measure

Composite of all-cause death and rehospitalization for any reason [ Time Frame: 30 days ]

Central Contacts

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