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

NCT07425132 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-02-20

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Heart Disease

Interventions

DIAGNOSTIC_TEST

Electrocardiographic imaging

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.

Sponsors & Collaborators

  • Fundacion para la Innovacion en Biomedicina (FIBMED)

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07425132 on ClinicalTrials.gov