NCT05772182

Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 362 (actual)
• Sponsor: Corify Care S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
DEVICE	ACORYS MAPPING SYSTEM	Diagnostic Test: ECG-Imaging Diagnostic Test: Standard 12-lead ECG Diagnostic Test: Endocardial mapping and/or pacing

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-01-13
• Completion: 2026-01-13
• First posted: 2023-03-16
• Last updated: 2026-02-17

Locations

3 sites across 1 country: Spain