NCT07425132 Non-Invasive Electrocardiographic Imaging for Personalized Arrhythmia Care in Congenital Heart Disease
| NCT ID | NCT07425132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion para la Innovacion en Biomedicina (FIBMED) |
| Condition | Congenital Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-02 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients with congenital pathologies and a clinical indication for an invasive electroanatomical study and/or implantation of intracavitary stimulation devices. * Written informed consent form signed to participate in the study. * Ability to stand upright to allow for the 3D torso reconstruction required by the ECGI system. Exclusion Criteria: * Patients under 18 years of age. * Inability to undergo endocardial catheterization (e.g., pregnant or breastfeeding women). * Physical or mental incapacity to understand and accept the informed consent.