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NCT07501299RecruitingAccepts Healthy Volunteers

HeartBeam ECG Registry

HeartBeam, Inc.

Start Date

3/30/2026

Completion Date

12/1/2028

Summary

The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Undergoing ECG as part of standard of care. 2. Able and willing to provide written informed consent. Exclusion Criteria: 1. 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.

Interventions

DIAGNOSTIC_TEST

Electrocardiogram (ECG)

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Conditions

Atrial FibrillationAtrial FlutterBradycardiaTachycardiaArrhythmia

Locations

Allegheny Health Network

Pittsburgh, Pennsylvania 15212

United States