An interventional study of Vectorcardiography (VECG) in Arrhythmias, Cardiac, Atrial Fibrillation and Atrial Flutter, sponsored by HeartBeam, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by HeartBeam, Inc. · Not applicable, Interventional, and Diagnostic
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.
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.
Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions:
Exclusion Criteria:
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)
Patients enrolled will undergo diagnostic ECG recording: three sets of simultaneous 30s recordings with the investigational device AIMIGo and a standard 12L ECG.
Also known as: HeartBeam AIMIGo VECG System
Clinical equivalence of ECG intervals compared between AIMIGo Synthesized 12L and reference standard 12L
Quantitative analysis on ECG intervals of the median beat of a 30s simultaneously recorded ECG from study and reference device.
Time frame: 30 seconds recording
Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L
Quantitative analysis on ECG amplitudes of the median beat of a 30s simultaneously recorded ECG from study and reference device.
Time frame: 30 seconds recording
Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia.
Summary statistics demonstrating agreement on arrhythmia diagnoses between the two devices will be performed
Time frame: 30 seconds recording
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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HeartBeam, Inc.