HeartBeam ECG Registry | Clinical Trial

Key information

Conditions

Atrial Fibrillation Arrhythmia Arrhythmias, Cardiac Atrial Flutter Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location status: Recruiting

Location contact

Caitlin Phalunas

CONTACT

[email protected]

4123593747

Joshua Silverstein, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrocardiogram (ECG)

Diagnostic Test

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.

Primary outcomes

Creation of a de-identified ECG dataset for future research and regulatory use

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pooja Chatterjee

CONTACT

[email protected]

408-899-4443

Sponsors and collaborators

Lead sponsor

HeartBeam, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Mar 30, 2026
Registry last updated: Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting