Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias

NCT05772182 | Completed DMC

• 1 other identifier: SAVE-COR
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cardiac Arrhythmia

Keywords

Non-invasive; Electrocardiographic imaging (ECGI)

Outcome Measures

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.

  1 year

Secondary Outcomes (3)

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

  1 year

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

  1 year

• Cost-effectiveness rate of the ECGI

  1 year

Study Arms (1)

Groups/Cohorts

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

Device: ACORYS MAPPING SYSTEM

Interventions

ACORYS MAPPING SYSTEM DEVICE

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

Groups/Cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \<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).

Sponsors & Collaborators

• Corify Care S.L.: lead
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Universitario La Fe: collaborator

Study Sites (3)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: December 1, 2022
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)