Non-invasive 3D ECG mapping to guide arrhythmia care in congenital heart disease
Non-Invasive Electrocardiographic Imaging for Personalized Arrhythmia Care in Congenital Heart Disease
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 |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fundacion para la Innovacion en Biomedicina (FIBMED) Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07425132 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Madrid, Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.