AI-Powered heart patch could spot irregular rhythms at home
NCT ID NCT07188129
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether an artificial intelligence algorithm (ZywieAI) can accurately analyze heart rhythm data collected from a wearable sensor (ZywieZ3) worn for 24 hours. The sensor was placed in non-traditional positions on the chest. Researchers compared the AI's findings with assessments from cardiologists. The goal is to see if this technology can reliably detect conditions like atrial fibrillation, tachycardia, and other heart rhythm issues.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ZywieAI algorithm and ZywieZ3 wearable ECG sensor
- What this could lead to
- If successful, this could lead to a more convenient way to monitor heart rhythms at home using a wearable patch, potentially improving detection of arrhythmias.
- What could go wrong
- This is a small, completed device validation study, not a treatment trial. The algorithm may not perform as well in real-world settings or with diverse patient groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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153 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Of the 150 subjects who complete the study, at least 60 (i.e., ≥ 40%) subjects must be male, and at least 60 (i.e., ≥ 40%) subjects must be female. * Subjects must be more than 18 years of age. * Subjects' body mass index (BMI) will be calculated based on their weight and height at the time of consent. BMI will be calculated using the CDC's online Adult BMI Calculator (https://www.cdc.gov/healthyweight/assessing/bmi/adult\_bmi/english\_bmi\_calculator/bmi\_calculator.html). This calculator will also automatically categorize the calculated BMI as underweight to healthy (\< 18.5 to 24.9), overweight (25.0 to 29.9), or obese (≥ 30.0). Of the 150 subjects who complete the study, no more than 70 subjects can be from a given BMI category. * Subjects must be able to read, write, and understand English. * Subjects must be in good general health (i.e., no current or recent severe illness). * Subjects must have a known condition of Atrial Fibrillation (AF), Tachycardia, Bradycardia, Premature Ventricular Contractions (PVC/VEB), and/or Premature Atrial Contractions (PAC) diagnosed by a medical professional. * Subjects with body hair on their upper-left chest must be willing to have the body hair clipped by a Testing Facility analyst before applying the Test Device. * Subjects must be willing to have their upper-left chest cleaned with 70% isopropanol preparation pads before applying the Test Device. Exclusion Criteria: * Subjects cannot be currently participating in another clinical study. * Subjects cannot have active skin rashes, dermatoses, or breaks in the skin on the upper left chest region. * Subjects cannot have undergone any surgeries during the last 3 months involving incisions along their upper-left chest. * Subjects cannot have any tattoos on their upper-left chest. * Subjects cannot have currently active inflammatory skin conditions (e.g., atopic dermatitis/eczema, contact dermatitis, or psoriasis) anywhere on the body within 2 days of the start of the test period and during the 24-hour test period. * Subjects cannot have a medical diagnosis of an organ transplant, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis. * Subjects cannot have a pacemaker. * Subjects cannot have any type of port, shunt, or Peripherally Inserted Central Catheter (PICC). * Subjects cannot receive any vaccinations within 7 days of the start of the test period and while participating in the 24-hour test period. * Subjects cannot have known allergies or sensitivities to latex (natural rubber), adhesives, inks, sunscreens, deodorants, laundry detergents, cleansers, soaps, lotions, to topical application of fragrances (e.g., perfumes or colognes), acrylic, hydrogel, isopropyl alcohol, C11-12 isoparaffin, isopropyl palmitate, isopropyl myristate, or isopropyl stearate. * Subjects cannot be pregnant, plan to become pregnant, or cause a partner to become pregnant during the study. * Subjects cannot be nursing a child during the 24-hour test period. * Subjects cannot have any medical condition or use any medications that, in the opinion of the Principal Investigator or Consulting Physicians, should preclude participation or might impact data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bioscience of Bozeman, LLC
Bozeman, Montana, 59715, United States
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Other studies related to the condition(s) this trial covers.
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