Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital General Universitario Gregorio Marañon | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Hospital Universitario La Fe | OTHER |
Not provided
Not provided
Not provided
Not provided
Noninvasive evaluation of the electrical status of the heart is based on the standard ECG but remains suboptimal due to difficulties with arrhythmia characterization and location. Electrocardiographic Imaging (ECGI) provides maps of cardiac electrical excitation in relation to the anatomy of the heart using an extensive number of electrodes from the body surface. The applicant will develop a systematic evaluation of the ECGI as a tool to detect cardiac regions of interest in cardiac arrhythmias.
The specific aim of this multicenter observational study is to evaluate the precision of non-invasive cardiac mapping system ECGI using multipolar intracardiac recordings as the gold standard. We will develop a non-invasive ECGi and intracardiac recordings in patients undergoing electrophysiology studies and/or intracardiac devices implantation to correlate the position of the regions of interest at predefined anatomy sites in patients with different organized arrhythmias. The long-term outcome of the electrophysiological characterization using ECGI will be also evaluated. Finally, the cost-efficiency of ECGI system as a support tool in cardiac arrhythmias diagnosis will be assessed.
Objectives: to perform a systematic evaluation of the ECGI with recordings using multipolar intracardiac recordings as the gold standard. Secondly, the study will also validate the ability of the ECGI recordings to increase the precision of the standard ECG interpretation by an expert.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groups/Cohorts | Patients undergoing intervention for arrhythmia (electrophysiologic study and/or intracardiac device implantation) with clinical indication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACORYS MAPPING SYSTEM | Device | Diagnostic Test: ECG-Imaging Diagnostic Test: Standard 12-lead ECG Diagnostic Test: Endocardial mapping and/or pacing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of ECGI for detecting cardiac region of interest | Accuracy of the ECGI non-invasive cardiac mapping system for detecting cardiac regions of interest in cardiac arrhythmias through direct confrontation with invasive endocardial contact measures. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of ECGI with an expert's interpretation of the standard ECG | Correlation of ECGI with an expert's interpretation of the standard ECG in terms of identifying a cardiac region of interest in an arrhythmia. | 1 year |
| ECGI's ability to accurately predict the success of ablation procedures and recurrence |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The patient's population will include those with an indication for an invasive electroanatomic study and/or intracardiac device implantation.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Barcelona | Barcelona | 08036 | Spain | ||
| Hospital General Universitario Gregorio Marañón |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40293957 | Derived | Reventos-Presmanes J, Fambuena C, Cano-Cabanero A, Correas M, Hernandez-Romero I, Herrero-Martin C, Lundback D, Llorente I, Martinez M, Moreno-Lopez R, Molero R, Milagro J, Pellicer-Sendra B, Regany M, Ros S, Serrano J, Vicente J, Zacur E, Althoff T, Arbelo E, Arenal A, Avila P, Carta-Bergaz A, Guasch E, Guichard JB, Izquierdo M, Pujol-Lopez M, Porta-Sanchez A, Roca-Luque I, Tolosana JM, Torrecilla EG, Osca J, Mont L, Atienza F, Guillem MS, Climent AM. Real-Time Cardiac Mapping with a Noninvasive Imageless Electrocardiographic Imaging System. J Vis Exp. 2025 Apr 11;(218). doi: 10.3791/67958. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Degree of concordance of the electrophysiological characterization obtained by ECGI with the success of ablation procedures and recurrence. |
| 1 year |
| Cost-effectiveness rate of the ECGI | Cost-effectiveness rate of the ECGI as a support tool in the diagnosis of cardiac arrhythmias. | 1 year |
| Madrid |
| Madrid |
| 28007 |
| Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | Valencia | 46026 | Spain |