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

NCT07425132 | Recruiting

• 1 other identifier: EPIC
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Electrocardiography; ECGi; Congenital heart disease; Cardiac arrhythmias

Outcome Measures

Primary Outcomes (2)

• Geometry threshold complexity

  Validation of Statistical vs. Personalized Geometry: A primary objective is to determine the "threshold of complexity" where statistical models fail. In minor structural variations, statistical estimation may suffice, reducing radiation and costs. However, in major congenital malformations, the study hypothesizes that personalized CT/MRI segmentation is essential for maintaining spatial accuracy.

  1 year

• ECGi and invasive mapping correlation

  Agreement with Invasive Mapping: By correlating non-invasive epicardial maps with high-density intracavitary electrograms (EGM), the study seeks to validate the ECGI system's precision in identifying conduction blocks, rotational drivers, or focal triggers specific to the CHD population.

  1 year

Secondary Outcomes (3)

• Sensitivity and specificity of ECGI vs. 12-lead ECG

  1 year

• Mean distance error (in mm) between statistical geometry maps and CT/MRI-based maps

  1 year

• Procedural time impact of incorporating non-invasive mapping data (in minutes)

  1 year

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) diagnosed with congenital heart disease (simple, moderate, or complex congenital heart defects ranging from atrial septal defects to complex single-ventricle anatomies such as Fontan circulation) who are referred to the Electrophysiology Unit or Cardiology Department for clinical management of arrhythmias. Eligible patients will be invited to participate during their pre-procedural consultation or upon admission for their scheduled intervention. Specifically, participants will be selected from the following clinical streams: (1) Catheter ablation candidates presenting with symptomatic tachyarrhythmias (atrial or ventricular) that have a clinical indication for an invasive electroanatomical mapping and ablation procedure (2) Device implantation candidates referred for the implantation or upgrade of intracavitary stimulation devices, including permanent pacemakers, ICDs or CRT. The recruitment process aims to capture a representative spectrum of CHD complexity,

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Innovacion en Biomedicina (FIBMED): lead

Study Sites (1)

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Felipe Atienza, MD, PhD

CONTACT

0034915868290; felipe.atienza@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)