HeartBeam ECG Registry
Purpose
The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.
Conditions
- Atrial Fibrillation
- Atrial Flutter
- Bradycardia
- Tachycardia
- Arrhythmia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Undergoing ECG as part of standard of care. 2. Able and willing to provide written informed consent.
Exclusion Criteria
- Open chest wounds or surgery to the chest or abdomen within 30 days. 2. Inability to complete ECG acquisition with either HeartBeam device or standard 12-L ECG. 3. Unstable condition where registry participation may interfere with care.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Pittsburgh, Pennsylvania 15212
More Details
- Status
- Recruiting
- Sponsor
- HeartBeam, Inc.
Detailed Description
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.