Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias

Cardiac Arrhythmia Clinical Trial

— SAVE-COR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772182
• Other study ID #: SAVE-COR
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: Corify Care S.L.
• Contact: Felipe Atienza, MD, PhD
• Phone: 915868000
• Email: felipe.atienza[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• ACORYS MAPPING SYSTEM
Diagnostic Test: ECG-Imaging Diagnostic Test: Standard 12-lead ECG Diagnostic Test: Endocardial mapping and/or pacing

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitari i Politècnic La Fe	Valencia

Sponsors (4)

Lead Sponsor	Collaborator
Corify Care S.L.	Hospital Clinic of Barcelona, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Cost-effectiveness rate of the ECGI	Cost-effectiveness rate of the ECGI as a support tool in the diagnosis of cardiac arrhythmias.	1 year