AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

Study Overview
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Brief Summary
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The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.

Detailed Description
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The purpose of this study is to conduct clinical validation of the AIMIGo 12-lead Synthesis Software against a standard FDA-cleared 12-lead ECG system, based on quantitative and qualitative assessment of paired recordings from the same patient, in sinus rhythm or during episodes of symptomatic non-life-threatening arrhythmia. The study will provide the necessary data for an FDA 510(k) regulatory submission and develop experience for market access and integration into clinical workflows.

Official Title
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Clinical Validation of the AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study

Conditions
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Bradycardia, Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Tachycardia

Intervention / Treatment
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* Device: Vectorcardiography (VECG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects over 18 years of age. Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions: Previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation. Patients with symptoms indicative of cardiac arrhythmias. Able and willing to sign informed consent. Exclusion Criteria: Open chest wounds or recent (<30 days) surgery to the chest or abdomen. Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinic. | Device: Vectorcardiography (VECG)<br>* Patients enrolled will undergo diagnostic ECG recording: three sets of simultaneous 30s recordings with the investigational device AIMIGo and a standard 12L ECG.<br>* Other names: HeartBeam AIMIGo VECG System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint measured as differences in intervals/durations and amplitudes between standard 12L ECG and AIMIGo synthesized 12L ECG taken simultaneously | Intervals: PQ, QRS, QT, RR Amplitudes: P-wave, R-wave, T-wave Measured on median beats | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical diagnostic accuracy | Measured by Sensitivity and Specificity of synthesized 12L ECG compared with the standard 12L ECG for the classification of arrythmia | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, Telemedicine, Cardiac Arrhythmia, Synthesis Software, Diagnostic, Vectorcardiography, Remote Monitoring