Clinical trial NCT05772182: Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias
Official title: Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias (SAVE-COR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmia
Keywords: Non-invasive
Electrocardiographic imaging (ECGI)
Lead sponsor: Corify Care S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital General Universitario Gregorio Marañon
name: Hospital Clinic of Barcelona
name: Hospital Universitario La Fe
First posted: 2023-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Accuracy of ECGI for detecting cardiac region of interest
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of ECGI with an expert's interpretation of the standard ECG
timeFrame: 1 year
measure: ECGI's ability to accurately predict the success of ablation procedures and recurrence
timeFrame: 1 year
measure: Cost-effectiveness rate of the ECGI
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
References: