Atrial Fibrillation (AF)NCT07188129
Evaluation of a Test Algorithm for Use to Analyze ECG Data Collected From a Test Device of a 24-hour Simulated Use Period
A study testing Test Algorithm and Test Device in people with Atrial Fibrillation (AF) and Tachycardia, run by Zywie, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Tachycardia, Bradycardia
- What is being tested?
- Test Algorithm and Test Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Compatibility of the ZywieAI Algorithm to Analyze ECG Data Collected From the Zywiez3 Sensor and Adhesive Over a 24-hour Period
The purpose of this study is to demonstrate that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects.
Read the detailed description
At least 150 subjects will participate in this study over a 24-hour test period. The subjects must have been diagnosed with a known condition such as Atrial Fibrillation (AF), Tachycardia, Bradycardia, Premature Ventricular Contractions (PVC/VEB), and/or Premature Atrial Contractions (PAC), etc.
A Testing Facility analyst will conduct an initial visual evaluation of the level of skin adhesion for the Test Device. The Testing Facility analyst will apply the Test device adhesive on the subject and initiate ECG data collection. Subjects will observe a 5-minute stabilization period to ensure the device is connected appropriately and has a stable input signal. Subjects will be allowed to leave the Testing Facility for the next 24 hours. During this period, subjects will follow the instructions for use provided by the Sponsor and engage in normal routine activities. After the 24-hour recording, subjects will return to the Testing Facility, and an analyst will then remove the Test Device.
Two cardiologists will review the collected ECG data from the 24-hour wear time to identify episodes of arrhythmia. A third cardiologist will be used to review the ECG data collected if the first two do not agree with their assessment. The Sponsor will download the ECG data for the Test Device from a cloud-based data repository to complete the data analysis according to the Sponsor's statistical analysis plan. The cardiologist's assessment will be compared with the analysis by the ZywieAI algorithm. A summary of the ECG statistical analysis comparing the agreement of the cardiologists will be included as an appendix to the final report for the study.
- Conditions
- Atrial Fibrillation (AF), Tachycardia, Bradycardia, PVC - Premature Ventricular Contraction, Premature Atrial Contraction
- Being tested
- Test Algorithm and Test Device
- Keywords
- ECG Evaluation Algorithm, Simulated ECG Use
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Bradycardia, Ventricular Premature Complexes, Atrial Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Algorithm and Test DeviceDevice
Test Algorithm analysis of 24-hour ECG Data collected with a Test Device
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of 24-hour ECG Data from Test Device by a Test Analysis Algorithm | Other | ECG data will be collected from subjects with previously diagnosed heart arrhythmias by a test algorithm. ECG data collected using a Test Device with non-traditional lead placement worn for a 24-hour period. The Test Algorithm analysis will be compared to assessments of the ECG data by 2 cardiologists with a 3rd cardiologist employed when there is no agreement by the 2 cardiologists. Receives: Device: Test Algorithm and Test Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects
Two cardiologists will review the collected ECG data from the 24-hour wear time to identify episodes of arrhythmia. A third cardiologist will be used to review the ECG data collected if the first two do not agree with their assessment. The Sponsor will download the ECG data for the Test Device from a cloud-based data repository to complete the data analysis by ZywieAI algorithm identifying cardiac anomalies. The cardiologist's assessment will be compared with the analysis by the ZywieAI.
Measured: 24 Hours after Application of Test Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start20 Jan 2025
- Primary completion6 May 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zywie, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher M Beausoleil, B.S., Principal investigator, Bioscience of Bozeman LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188129
- Sponsor's protocol ID
- 2410003-150
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans for publishing the data from this trial.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Compatibility of the ZywieAI Algorithm to Analyze ECG Data Collected From the Zywiez3 Sensor and Adhesive Over a 24-hour Period
- ClinicalTrials.gov ID
- NCT07188129
- Acronym / sponsor ID
- 2410003-150
- Conditions
- Atrial Fibrillation (AF), Tachycardia, Bradycardia, PVC - Premature Ventricular Contraction, Premature Atrial Contraction
- Keywords
- ECG Evaluation Algorithm, Simulated ECG Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Zywie, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects.
Detailed description
At least 150 subjects will participate in this study over a 24-hour test period. The subjects must have been diagnosed with a known condition such as Atrial Fibrillation (AF), Tachycardia, Bradycardia, Premature Ventricular Contractions (PVC/VEB), and/or Premature Atrial Contractions (PAC), etc.
A Testing Facility analyst will conduct an initial visual evaluation of the level of skin adhesion for the Test Device. The Testing Facility analyst will apply the Test device adhesive on the subject and initiate ECG data collection. Subjects will observe a 5-minute stabilization period to ensure the device is connected appropriately and has a stable input signal. Subjects will be allowed to leave the Testing Facility for the next 24 hours. During this period, subjects will follow the instructions for use provided by the Sponsor and engage in normal routine activities. After the 24-hour recording, subjects will return to the Testing Facility, and an analyst will then remove the Test Device.
Two cardiologists will review the collected ECG data from the 24-hour wear time to identify episodes of arrhythmia. A third cardiologist will be used to review the ECG data collected if the first two do not agree with their assessment. The Sponsor will download the ECG data for the Test Device from a cloud-based data repository to complete the data analysis according to the Sponsor's statistical analysis plan. The cardiologist's assessment will be compared with the analysis by the ZywieAI algorithm. A summary of the ECG statistical analysis comparing the agreement of the cardiologists will be included as an appendix to the final report for the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of 24-hour ECG Data from Test Device by a Test Analysis Algorithm | Other | Device: Test Algorithm and Test DeviceECG data will be collected from subjects with previously diagnosed heart arrhythmias by a test algorithm. ECG data collected using a Test Device with non-traditional lead placement worn for a 24-hour period. The Test Algorithm analysis will be compared to assessments of the ECG data by 2 cardiologists with a 3rd cardiologist employed when there is no agreement by the 2 cardiologists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Algorithm and Test DeviceTest Algorithm analysis of 24-hour ECG Data collected with a Test Device | Device | Evaluation of 24-hour ECG Data from Test Device by a Test Analysis Algorithm |
Primary outcome
Demonstration that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects
Time frame: 24 Hours after Application of Test Device
Two cardiologists will review the collected ECG data from the 24-hour wear time to identify episodes of arrhythmia. A third cardiologist will be used to review the ECG data collected if the first two do not agree with their assessment. The Sponsor will download the ECG data for the Test Device from a cloud-based data repository to complete the data analysis by ZywieAI algorithm identifying cardiac anomalies. The cardiologist's assessment will be compared with the analysis by the ZywieAI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No. There are no plans for publishing the data from this trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher M Beausoleil, B.S. principal investigator
Bioscience of Bozeman LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Algorithm and Test Device in people with Atrial Fibrillation (AF) and Tachycardia, run by Zywie, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects (time frame: 24 Hours after Application of Test Device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.