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CompletedNCT05772182SAVE-CORUpdated Feb 17, 2026

Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias

An observational study in Cardiac Arrhythmia, sponsored by Corify Care S.L.. Completed at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Corify Care S.L. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
362
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Cardiac Arrhythmia

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Keywords

  • Non-invasive
  • Electrocardiographic imaging (ECGI)
03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's enrollment of 362 is above the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

This is the only study on the registry with Corify Care S.L. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The patient's population will include those with an indication for an invasive electroanatomic study and/or intracardiac device implantation.

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
362 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Groups/Cohorts

    Patients undergoing intervention for arrhythmia (electrophysiologic study and/or intracardiac device implantation) with clinical indication

    Device: ACORYS MAPPING SYSTEM

Interventions

  • DeviceACORYS MAPPING SYSTEM

    Diagnostic Test: ECG-Imaging Diagnostic Test: Standard 12-lead ECG Diagnostic Test: Endocardial mapping and/or pacing

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. Cost-effectiveness rate of the ECGI

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

    Time frame: 1 year

07

Study locations

3 sites
  • Hospital Clínic de Barcelona
    Barcelona, Barcelona 08036, Spain
  • Hospital General Universitario Gregorio Marañón
    Madrid, Madrid 28007, Spain
  • Hospital Universitari i Politècnic La Fe
    Valencia, Valencia 46026, Spain
08

References and documents

Publications

  • 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. PubMed 40293957 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05772182
Lead sponsor
Corify Care S.L.
Collaborators
Hospital General Universitario Gregorio Marañon, Hospital Clinic of Barcelona, Hospital Universitario La Fe
Responsible party
Sponsor
First posted
Mar 16, 2023
Start date
Dec 1, 2022
Primary completion
Jan 13, 2025
Completion
Jan 13, 2026
Last update
Feb 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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