NCT07501299

HeartBeam ECG Registry

Collection of ECG Recordings Using the HeartBeam 3-Lead ECG Recorder

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: HeartBeam, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atrial Fibrillation
• Atrial Flutter
• Bradycardia
• Tachycardia
• Arrhythmia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Electrocardiogram (ECG)	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study