Non-invasive 3D ECG mapping to guide arrhythmia care in congenital heart disease
Official title: Non-Invasive Electrocardiographic Imaging for Personalized Arrhythmia Care in Congenital Heart Disease
Run by Fundacion para la Innovacion en Biomedicina (FIBMED) · NCT07425132 · Data updated 2026-11-12
This project will test a non-invasive 3D ECG mapping system to see if it can pinpoint arrhythmia sources in people with congenital heart disease who are having invasive heart rhythm studies or device implants.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Fundacion para la Innovacion en Biomedicina (FIBMED) Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | February 2026 |
| Main results expected | December 2026 |
| Study ends | July 2027 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT07425132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with congenital heart disease who have a clinical indication for an invasive electroanatomical study or intracavitary device implantation, can stand for 3D torso reconstruction, and can provide informed consent.
✕Probably not a fit
Children under 18, pregnant or breastfeeding individuals, people who cannot undergo endocardial catheterization, or those unable to stand for the torso scan are unlikely to benefit or be eligible for this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective pilot enrolls adults with congenital heart disease who are scheduled for invasive electroanatomical studies or intracavitary device implantation. Participants undergo a non-invasive Electrocardiographic Imaging (ECGI) recording with a 3D torso reconstruction that can use statistical estimation to generate cardiac geometry, potentially avoiding CT/MRI in routine cases. Findings from the ECGI system will be compared to invasive electroanatomical mapping performed during the clinical procedure to measure accuracy and clinical utility. The study tests whether the non-invasive maps can reliably identify arrhythmogenic regions and help plan ablation or device therapy.
Why it matters
Potential benefit: If successful, the technology could allow more accurate, non-invasive identification of arrhythmia sources to improve planning and precision of ablation or device procedures.
How similar studies have gone: Non-invasive ECGI has shown promising results in other arrhythmia populations, but applying statistical geometry generation without CT/MRI in congenital heart disease is a novel approach with limited prior validation.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: Felipe Atienza, MD, PhD
- Email: felipe.atienza@salud.madrid.org
- Phone: 0034915868290
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.