Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias (SAVE-COR)

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Device: ACORYS MAPPING SYSTEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for an invasive electroanatomic study and/or intracardiac device implantation. Having obtained and signed the informed consent for study participation. Ability to stand, to be able to obtain the 3D torso reconstruction necessary for the ECGI system. Exclusion Criteria: <18 years old Inability to perform an endocardial catheterization and/or device implantation. Physical or mental disability to understand and accept the informed consent. Inability to stand to obtain the 3D torso reconstruction. active coronary ischemia or decompensated heart failure Intracardiac clot on trans-esophageal echocardiography Pregnancy. Disorganized arrhythmias (i.e. atrial fibrillation, polymorphic ventricular tachycardia).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Groups/Cohorts<br>Patients undergoing intervention for arrhythmia (electrophysiologic study and/or intracardiac device implantation) with clinical indication | Device: ACORYS MAPPING SYSTEM<br>* Diagnostic Test: ECG-Imaging Diagnostic Test: Standard 12-lead ECG Diagnostic Test: Endocardial mapping and/or pacing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive, Electrocardiographic imaging (ECGI)