HeartBeam ECG Registry

NCT07501299 | Not Yet Recruiting FDA Device

• 1 other identifier: HER
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation; Atrial Flutter; Bradycardia; Tachycardia; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Undergoing ECG as part of standard of care Able and willing to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• HeartBeam, Inc.: lead

Study Sites (1)

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Bradycardia; Tachycardia; Arrhythmias, Cardiac

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Pooja Chatterjee

CONTACT

408-899-4443; pchatterjee@heartbeam.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)