Cardiac ArrhythmiaSAVE-CORNCT05772182
Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias
An observational study of Cardiac Arrhythmia, run by Corify Care S.L. at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- ACORYS MAPPING SYSTEM
- Type of treatment
- Medical device
- How many people
- 362 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Dec 2022to 13 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The patient's population will include those with an indication for an invasive electroanatomic study and/or intracardiac device implantation.
Who may be able to join
- 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.
Who cannot join
- <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).
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
About this study
Official title: Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias (SAVE-COR)
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.
- Conditions
- Cardiac Arrhythmia
- Being tested
- ACORYS MAPPING SYSTEM
- Keywords
- Non-invasive, Electrocardiographic imaging (ECGI)
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACORYS MAPPING SYSTEMDevice
Diagnostic Test: ECG-Imaging
Diagnostic Test: Standard 12-lead ECG
Diagnostic Test: Endocardial mapping and/or pacing
| Study group | Role | What they receive |
|---|---|---|
| Groups/Cohorts | Patients undergoing intervention for arrhythmia (electrophysiologic study and/or intracardiac device implantation) with clinical indication Receives: Device: ACORYS MAPPING SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 1 year
Cost-effectiveness rate of the ECGI
Cost-effectiveness rate of the ECGI as a support tool in the diagnosis of cardiac arrhythmias.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Dec 2022
- Primary completion13 Jan 2025
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Corify Care S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital General Universitario Gregorio Marañon, Hospital Clinic of Barcelona, Hospital Universitario La Fe
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772182
- Sponsor's protocol ID
- SAVE-COR
- Acronym
- SAVE-COR
- Status last verified
- Feb 2026
- First submitted
- 6 Mar 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias (SAVE-COR)
- ClinicalTrials.gov ID
- NCT05772182
- Acronym / sponsor ID
- SAVE-COR / SAVE-COR
- Conditions
- Cardiac Arrhythmia
- Keywords
- Non-invasive, Electrocardiographic imaging (ECGI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Corify Care S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital General Universitario Gregorio Marañon, Hospital Clinic of Barcelona, Hospital Universitario La Fe
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Groups/Cohorts | – | Device: ACORYS MAPPING SYSTEMPatients undergoing intervention for arrhythmia (electrophysiologic study and/or intracardiac device implantation) with clinical indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patient's population will include those with an indication for an invasive electroanatomic study and/or intracardiac device implantation.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACORYS MAPPING SYSTEMDiagnostic Test: ECG-Imaging Diagnostic Test: Standard 12-lead ECG Diagnostic Test: Endocardial mapping and/or pacing | Device | Groups/Cohorts |
Primary outcome
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.
3 secondary outcomes
Correlation of ECGI with an expert's interpretation of the standard ECG
Time frame: 1 year
ECGI's ability to accurately predict the success of ablation procedures and recurrence
Time frame: 1 year
Cost-effectiveness rate of the ECGI
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 40293957Reventos-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Corify Care S.L. at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ECGI for detecting cardiac region of interest (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05772182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.