Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.
This study aims to collect electrocardiogram (ECG) recordings using the HeartBeam System across a broad range of cardiac conditions and patient populations. Data collection will include various rhythm types (e.g., sinus rhythm, atrial fibrillation, atrial flutter, ectopic beats, and other non-life-threatening arrhythmias), conduction disorders, and heart rate abnormalities (including bradycardia and tachycardia). The study will also ensure representation across diverse patient subgroups defined by race, ethnicity, age, sex, body mass index (BMI), and comorbidities.
A de-identified ECG database will be established from the collected data to support future research and regulatory activities, including evaluation of device performance across different rhythm types and patient subpopulations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocardiogram (ECG) | Diagnostic Test | The intervention consists of non-invasive ECG recordings obtained using the HeartBeam System. Participants will use the device to capture cardiac electrical activity for assessment of heart rhythm, conduction patterns, and heart rate abnormalities in a clinical setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Creation of a de-identified ECG dataset for future research and regulatory use | ECG recordings collected during the study will be de-identified and compiled into a database that may be used by HeartBeam for future research and regulatory submissions. The collected data are for observational purposes only and will not be used for clinical decision-making. | 2 years |
Not provided
Not provided
Inclusion Criteria:
Undergoing ECG as part of standard of care Able and willing to provide written informed consent
Exclusion Criteria:
Open chest wounds or surgery to the chest or abdomen within 30 days Inability to complete ECG acquisition with either HeartBeam device or standard 12-L ECG Unstable condition where registry participation may interfere with care
Not provided
Not provided
Not provided
The study will enroll adult participants representing a broad range of cardiac rhythms and clinical characteristics. This includes individuals with normal sinus rhythm as well as those with non-life-threatening arrhythmias, conduction abnormalities, and heart rate disorders (e.g., bradycardia and tachycardia). Efforts will be made to include a diverse population across race, ethnicity, age, sex, body mass index (BMI), and comorbid conditions to support evaluation of device performance across relevant subgroups.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pooja Chatterjee | Contact | 408-899-4443 | pchatterjee@heartbeam.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D001919 | Bradycardia |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
| D000075224 | Cardiac Conduction System Disease |
| D004568 | Electrodiagnosis |