Non-Invasive Electrocardiographic Imaging for Personalized Arrhythmia Care in Congenital Heart Disease

Sponsor
Fundacion para la Innovacion en Biomedicina (FIBMED)
Study ID
NCT07425132
Status
Recruiting
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Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Electrocardiographic imaging — DIAGNOSTIC_TEST
    A 128-electrode vest is placed on the patient's torso to record high-resolution body surface potentials. The torso geometry is then reconstructed using photogrammetry, capturing electrode positions and surface topology. The cardiac geometry can be either estimated through a Statistical Shape Model (SSM) generating a patient-specific representation of the heart or obtained by segmentation from CT/MRI. This enables non-invasively reconstructing the epicardial electrical activity of both atria and ventricles.

Study Details

To assess the accuracy and clinical utility of a novel non-invasive ECGI mapping system in identifying arrhythmogenic regions of interest in patients with congenital heart disease.

Key Dates

First listed
Feb 20, 2026
Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
15 participants (estimated)

Primary Outcome Measure

Geometry threshold complexity [ Time Frame: 1 year ]

Central Contacts

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