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RecruitingNCT07501299Updated Jul 20, 2026

HeartBeam ECG Registry

An observational study in Atrial Fibrillation, Atrial Flutter and Bradycardia, sponsored by HeartBeam, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by HeartBeam, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Atrial Fibrillation
  • Atrial Flutter
  • Bradycardia
  • Tachycardia
  • Arrhythmia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

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.

05

What researchers measure

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.

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Allegheny Health Network
    Pittsburgh, Pennsylvania 15212, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07501299
Lead sponsor
HeartBeam, Inc.
Responsible party
Sponsor
First posted
Mar 30, 2026
Start date
Mar 30, 2026
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 20, 2026

Study contacts

Pooja Chatterjee
Contact
pchatterjee@heartbeam.com
408-899-4443

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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