Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Bradycardia, Tachycardia
Conditions
Keywords
Telemedicine, Cardiac Arrhythmia, ECG, Synthesis Software, Diagnostic, Vectorcardiography, Remote Monitoring
Brief summary
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
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.
Interventions
DEVICEVectorcardiography (VECG)
Patients enrolled will undergo diagnostic ECG recording: three sets of simultaneous 30s recordings with the investigational device AIMIGo and a standard 12L ECG.
Sponsors
HeartBeam, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects over 18 years of age. 2. Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions: 1. Previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation. 2. Patients with symptoms indicative of cardiac arrhythmias. 3. Able and willing to sign informed consent.
Exclusion criteria
1. Open chest wounds or recent (\<30 days) surgery to the chest or abdomen. 2. Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical equivalence of ECG intervals compared between AIMIGo Synthesized 12L and reference standard 12L | 30 seconds recording | Quantitative analysis on ECG intervals of the median beat of a 30s simultaneously recorded ECG from study and reference device. |
| Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L | 30 seconds recording | Quantitative analysis on ECG amplitudes of the median beat of a 30s simultaneously recorded ECG from study and reference device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia. | 30 seconds recording | Summary statistics demonstrating agreement on arrhythmia diagnoses between the two devices will be performed |
Countries
United States
Outcome results
None listed