HeartBeam ECG Registry

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07501299

Enrollment

600

Registered

2026-03-30

Start date

2026-03-01

Completion date

2028-12-01

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Flutter, Bradycardia, Tachycardia, Arrhythmia

Brief 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.

Interventions

DIAGNOSTIC_TESTElectrocardiogram (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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Creation of a de-identified ECG dataset for future research and regulatory use	2 years	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.

Countries

United States

Contacts

CONTACTPooja Chatterjee

pchatterjee@heartbeam.com408-899-4443

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026