ACORYS MAPPING SYSTEM
DeviceDiagnostic Test: ECG-Imaging
Diagnostic Test: Standard 12-lead ECG
Diagnostic Test: Endocardial mapping and/or pacing
NCT Number: NCT05772182
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.
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Notify Me18 year and older
All sexes
Observational
Hospital Clínic de Barcelona, Barcelona, Spain
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diagnostic Test: ECG-Imaging
Diagnostic Test: Standard 12-lead ECG
Diagnostic Test: Endocardial mapping and/or pacing
Time frame: 1 year
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.
Time frame: 1 year
Correlation of ECGI with an expert's interpretation of the standard ECG in terms of identifying a cardiac region of interest in an arrhythmia.
Time frame: 1 year
Degree of concordance of the electrophysiological characterization obtained by ECGI with the success of ablation procedures and recurrence.
Time frame: 1 year
Cost-effectiveness rate of the ECGI as a support tool in the diagnosis of cardiac arrhythmias.
Corify Care S.L.
Industry
Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias (SAVE-COR)
Acronym: SAVE-COR
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