Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:41 PM
Study NCT ID:
NCT07425132
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Invasive Electrocardiographic Imaging for Personalized Arrhythmia Care in Congenital Heart Disease
Sponsor:
Fundacion para la Innovacion en Biomedicina (FIBMED)
Organization:
Study Overview
Official Title:
Non-Invasive Electrocardiographic Imaging for Personalized Arrhythmia Care in Congenital Heart Disease
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC
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.
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:
1. Body Surface Mapping: Placement of the 128-electrode vest and 3D torso reconstruction to localize electrode positions relative to the heart.
2. Standard 12-Lead ECG Acquisition: Traditional recordings are captured to serve as a baseline for head-to-head accuracy comparisons.
3. 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.
4. Anatomical Imaging Integration: Review of existing CT or MRI data (or acquisition based on clinical indication) to perform personalized segmentation.
5. 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.
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:
1. Body Surface Mapping: Placement of the 128-electrode vest and 3D torso reconstruction to localize electrode positions relative to the heart.
2. Standard 12-Lead ECG Acquisition: Traditional recordings are captured to serve as a baseline for head-to-head accuracy comparisons.
3. 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.
4. Anatomical Imaging Integration: Review of existing CT or MRI data (or acquisition based on clinical indication) to perform personalized segmentation.
5. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: