HeartBeam ECG Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrocardiogram (ECG).
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Atrial Flutter, Bradycardia, Tachycardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Collection of ECG Recordings Using the HeartBeam 3-Lead ECG Recorder
Overview
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 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.
Primary outcome measures
- Creation of a de-identified ECG dataset for future research and regulatory use [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Allegheny Health Network — Pittsburgh
Identifiers
NCT: NCT07501299 · HER