No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
2,000 (estimated)
Sponsor
Peerbridge Health, Inc · Industry
Who this trial is looking for
This trial is looking for adults who can wear a heart monitor to help assess how well their heart pumps blood. Participants will wear the monitor while resting, and their heart function results will be compared to another test to check the accuracy of the new technology.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I can wear a Holter monitor
You may not be able to join if
I am receiving mechanical or kidney support therapy
I have a condition that might make it hard to follow the study rules
I have had severe skin reactions to ECG adhesive materials
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleare…
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood.
In this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Able and eligible to wear a Holter monitor
Exclusion Criteria:
* Receiving mechanical respiratory or circulatory support, or renal support therapy, at the time of screening or during Visit #1
* Any condition that, in the investigator's opinion, could interfe…
Inclusion Criteria:
* Age ≥ 18 years
* Able and eligible to wear a Holter monitor
Exclusion Criteria:
* Receiving mechanical respiratory or circulatory support, or renal support therapy, at the time of screening or during Visit #1
* Any condition that, in the investigator's opinion, could interfere with compliance with the study protocol or pose a safety risk to the participant
* History of poor tolerance or severe skin reactions to ECG adhesive materials
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