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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vectorcardiography (VECG) | Device | Patients enrolled will undergo diagnostic ECG recording: three sets of simultaneous 30s recordings with the investigational device AIMIGo and a standard 12L ECG. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 seconds recording |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 seconds recording |
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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:
Able and willing to sign informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J. Fitzgerald, MD, PhD | HeartBeam, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States | ||
| Atlanta Heart Specialists |
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| Label | URL |
|---|---|
| HeartBeam Website | View source |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D001919 | Bradycardia |
| D013610 | Tachycardia |
| D004194 | Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014672 | Vectorcardiography |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Tucker |
| Georgia |
| 30084 |
| United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Long Island Jewish Medical Center | Queens | New York | 11040 | United States |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | United States |
| D000075224 | Cardiac Conduction System Disease |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |