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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: ACORYS MAPPING SYSTEM

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 Type: Observational
• Enrollment (Actual): 362

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08036
      • Hospital Clinic De Barcelona
  • Madrid
    • Madrid, Madrid, Spain, 28007
      • Hospital General Universitario Gregorio Marañón
  • Valencia
    • Valencia, Valencia, Spain, 46026
      • Hospital Universitari i Politecnic La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Corify Care S.L.
• Collaborators: Hospital General Universitario Gregorio Marañon; Hospital Clinic of Barcelona; Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): January 13, 2025
• Study Completion (Actual): January 13, 2026

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Non-invasive; Electrocardiographic imaging (ECGI)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac
• Other Study ID Numbers: SAVE-COR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No