HeartBeam ECG Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeartBeam, Inc.
About this trial
The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Undergoing ECG as part of standard of care.
Able and willing to provide written informed consent.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Electrocardiogram (ECG)
Diagnostic testThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov