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Completed

NCT Number: NCT05772182

Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínic de Barcelona, Barcelona, Spain

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ACORYS MAPPING SYSTEM

Device

Diagnostic Test: ECG-Imaging

Diagnostic Test: Standard 12-lead ECG

Diagnostic Test: Endocardial mapping and/or pacing

Primary outcomes

  1. Accuracy of ECGI for detecting cardiac region of interest

    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.

Secondary outcomes

  1. Correlation of ECGI with an expert's interpretation of the standard ECG

    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.

  2. ECGI's ability to accurately predict the success of ablation procedures and recurrence

    Time frame: 1 year

    Degree of concordance of the electrophysiological characterization obtained by ECGI with the success of ablation procedures and recurrence.

  3. Cost-effectiveness rate of the ECGI

    Time frame: 1 year

    Cost-effectiveness rate of the ECGI as a support tool in the diagnosis of cardiac arrhythmias.

Sponsors and collaborators

Lead sponsor

Corify Care S.L.

Industry

Collaborators

  • Hospital Clinic of Barcelona
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario La Fe

Registry information

Official study title

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

Acronym: SAVE-COR

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 16, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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