Congenital Heart DiseaseEPICNCT07425132
Non-Invasive Electrocardiographic Imaging for Personalized Arrhythmia Care in Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Fundacion para la Innovacion en Biomedicina (FIBMED) at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Electrocardiographic imaging
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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,
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007
Felipe Atienza, MD, PhD, 0034915868290, felipe.atienza@salud.madrid.org
About this study
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.
Read the detailed description
Congenital heart disease (CHD) survivors often present with complex anatomical remodeling and progressive atrial or ventricular arrhythmias that significantly impact their quality of life and long-term prognosis. Traditional diagnostic tools, such as the standard 12-lead ECG, frequently fall short in these patients due to displaced cardiac structures and atypical conduction pathways. While invasive electroanatomical mapping remains the gold standard for arrhythmia characterization, there is a critical clinical need for non-invasive, high-resolution tools that can streamline procedural planning and improve the precision of therapeutic interventions like catheter ablation or cardiac resynchronization therapy (CRT).
This single-center, prospective pilot study investigates the clinical utility and accuracy of a novel Electrocardiographic Imaging (ECGI) system. This system aims to overcome the limitations of conventional mapping by offering real-time, non-invasive 3D reconstruction of cardiac electrical activity. A key innovation of this technology is its ability to utilize statistical estimation algorithms to generate cardiac geometries, potentially bypassing the need for time-consuming medical image segmentation (CT/MRI) in standard cases, while allowing for personalized anatomical integration in complex congenital presentations.
Study Workflow
After obtaining informed consent, participants scheduled for elective electrophysiological (EP) studies or device implantations will follow a multi-modal diagnostic protocol:
- Body Surface Mapping: Placement of the 128-electrode vest and 3D torso reconstruction to localize electrode positions relative to the heart.
- Standard 12-Lead ECG Acquisition: Traditional recordings are captured to serve as a baseline for head-to-head accuracy comparisons.
- Intraoperative Invasive Mapping: During the clinical procedure, high-density endocardial mapping is performed using standard-of-care electroanatomical mapping systems to provide the definitive "ground truth" for arrhythmia localization.
- Anatomical Imaging Integration: Review of existing CT or MRI data (or acquisition based on clinical indication) to perform personalized segmentation.
- Comparative Analysis: A blinded expert review will compare the localization of "regions of interest" (ROI) between the ECGI system, the 12-lead ECG, and the invasive endocardial maps.
Patient Profile The trial focuses exclusively on patients with congenital heart disease, a cohort currently underrepresented in non-invasive mapping research. Eligible participants include those undergoing EP studies for tachycardia or those requiring device therapy (pacemakers/CRT) where optimal lead placement is critical.
Safety and Risk Mitigation The ECGI mapping process is entirely non-invasive and adds no procedural risk to the patient. No additional invasive maneuvers are required beyond what is already clinically indicated for the patient's standard care.
- Conditions
- Congenital Heart Disease
- Being tested
- Electrocardiographic imaging
- Keywords
- Electrocardiography, ECGi, Congenital heart disease, Cardiac arrhythmias
- Medical subject headings
- Heart Defects, Congenital, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiographic imagingDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
Sensitivity and specificity of ECGI vs. 12-lead ECG
Sensitivity and specificity of ECGI vs. 12-lead ECG
Measured: 1 year
Mean distance error (in mm) between statistical geometry maps and CT/MRI-based maps
Mean distance error (in mm) between statistical geometry maps and CT/MRI-based maps
Measured: 1 year
Procedural time impact of incorporating non-invasive mapping data (in minutes)
Procedural time impact of incorporating non-invasive mapping data (in minutes)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Innovacion en Biomedicina (FIBMED)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425132
- Sponsor's protocol ID
- EPIC
- Acronym
- EPIC
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Electrocardiographic Imaging for Personalized Arrhythmia Care in Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07425132
- Acronym / sponsor ID
- EPIC / EPIC
- Conditions
- Congenital Heart Disease
- Keywords
- Electrocardiography, ECGi, Congenital heart disease, Cardiac arrhythmias
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fundacion para la Innovacion en Biomedicina (FIBMED)University, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Congenital heart disease (CHD) survivors often present with complex anatomical remodeling and progressive atrial or ventricular arrhythmias that significantly impact their quality of life and long-term prognosis. Traditional diagnostic tools, such as the standard 12-lead ECG, frequently fall short in these patients due to displaced cardiac structures and atypical conduction pathways. While invasive electroanatomical mapping remains the gold standard for arrhythmia characterization, there is a critical clinical need for non-invasive, high-resolution tools that can streamline procedural planning and improve the precision of therapeutic interventions like catheter ablation or cardiac resynchronization therapy (CRT).
This single-center, prospective pilot study investigates the clinical utility and accuracy of a novel Electrocardiographic Imaging (ECGI) system. This system aims to overcome the limitations of conventional mapping by offering real-time, non-invasive 3D reconstruction of cardiac electrical activity. A key innovation of this technology is its ability to utilize statistical estimation algorithms to generate cardiac geometries, potentially bypassing the need for time-consuming medical image segmentation (CT/MRI) in standard cases, while allowing for personalized anatomical integration in complex congenital presentations.
Study Workflow
After obtaining informed consent, participants scheduled for elective electrophysiological (EP) studies or device implantations will follow a multi-modal diagnostic protocol:
- Body Surface Mapping: Placement of the 128-electrode vest and 3D torso reconstruction to localize electrode positions relative to the heart.
- Standard 12-Lead ECG Acquisition: Traditional recordings are captured to serve as a baseline for head-to-head accuracy comparisons.
- Intraoperative Invasive Mapping: During the clinical procedure, high-density endocardial mapping is performed using standard-of-care electroanatomical mapping systems to provide the definitive "ground truth" for arrhythmia localization.
- Anatomical Imaging Integration: Review of existing CT or MRI data (or acquisition based on clinical indication) to perform personalized segmentation.
- Comparative Analysis: A blinded expert review will compare the localization of "regions of interest" (ROI) between the ECGI system, the 12-lead ECG, and the invasive endocardial maps.
Patient Profile The trial focuses exclusively on patients with congenital heart disease, a cohort currently underrepresented in non-invasive mapping research. Eligible participants include those undergoing EP studies for tachycardia or those requiring device therapy (pacemakers/CRT) where optimal lead placement is critical.
Safety and Risk Mitigation The ECGI mapping process is entirely non-invasive and adds no procedural risk to the patient. No additional invasive maneuvers are required beyond what is already clinically indicated for the patient's standard care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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,
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocardiographic imagingA 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. | Diagnostic test | – |
Primary outcome
Geometry threshold complexity
Time frame: 1 year
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.
ECGi and invasive mapping correlation
Time frame: 1 year
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.
3 secondary outcomes
Sensitivity and specificity of ECGI vs. 12-lead ECG
Time frame: 1 year
Mean distance error (in mm) between statistical geometry maps and CT/MRI-based maps
Time frame: 1 year
Procedural time impact of incorporating non-invasive mapping data (in minutes)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Fundacion para la Innovacion en Biomedicina (FIBMED) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felipe Atienza, MD, PhD (0034915868290, felipe.atienza@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometry threshold complexity (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.