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

Sponsor

Corify Care S.L. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05772182

Collaborator

Hospital General Universitario Gregorio Marañon (Other), Hospital Clinic of Barcelona (Other), Hospital Universitario La Fe (Other)

Enrollment

Locations

Anticipated Duration (Months)

16.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmia	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Accuracy of ECGI for detecting cardiac region of interest [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 Outcome Measures

Correlation of ECGI with an expert's interpretation of the standard ECG [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.
ECGI's ability to accurately predict the success of ablation procedures and recurrence [1 year]
Degree of concordance of the electrophysiological characterization obtained by ECGI with the success of ablation procedures and recurrence.
Cost-effectiveness rate of the ECGI [1 year]
Cost-effectiveness rate of the ECGI as a support tool in the diagnosis of cardiac arrhythmias.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospital Clínic de Barcelona	Barcelona	Spain	08036
2	Hospital General Universitario Gregorio Marañón	Madrid	Spain	28007
3	Hospital Universitari i Politècnic La Fe	Valencia	Spain	46026

Sponsors and Collaborators

Corify Care S.L.
Hospital General Universitario Gregorio Marañon
Hospital Clinic of Barcelona
Hospital Universitario La Fe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Corify Care S.L.

ClinicalTrials.gov Identifier:

NCT05772182

Other Study ID Numbers:

SAVE-COR

First Posted:

Mar 16, 2023

Last Update Posted:

Mar 16, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Corify Care S.L.

Non-invasive

Electrocardiographic imaging (ECGI)

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Study Results

No Results Posted as of Mar 16, 2023