An observational study in Atrial Fibrillation, Atrial Flutter and Bradycardia, sponsored by HeartBeam, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by HeartBeam, Inc. · Observational
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.
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.
Exclusion Criteria:
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.
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.
Time frame: 2 years
Plan to share: No
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HeartBeam, Inc.