Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Groups/Cohorts

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

ACORYS MAPPING SYSTEM

Intervention Type DEVICE

Diagnostic Test: ECG-Imaging

Diagnostic Test: Standard 12-lead ECG

Diagnostic Test: Endocardial mapping and/or pacing

Interventions

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ACORYS MAPPING SYSTEM

Diagnostic Test: ECG-Imaging

Diagnostic Test: Standard 12-lead ECG

Diagnostic Test: Endocardial mapping and/or pacing

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No