Evaluation of a Test Algorithm for Use to Analyze ECG Data Collected From a Test Device of a 24-hour Simulated Use Period

NCT07188129 | Completed FDA Device

• 1 other identifier: 2410003-150
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF); Tachycardia; Bradycardia; PVC - Premature Ventricular Contraction; Premature Atrial Contraction

Keywords

ECG Evaluation Algorithm; Simulated ECG Use

Outcome Measures

Primary Outcomes (1)

• 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.

  24 Hours after Application of Test Device

Study Arms (1)

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.

Device: Test Algorithm and Test Device

Interventions

Test Algorithm and Test Device DEVICE

Test Algorithm analysis of 24-hour ECG Data collected with a Test Device

Evaluation of 24-hour ECG Data from Test Device by a Test Analysis Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zywie, Inc.: lead

Study Sites (1)

Bioscience of Bozeman, LLC

Bozeman, Montana, 59715, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia; Bradycardia; Ventricular Premature Complexes; Atrial Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Cardiac Complexes, Premature

Study Officials

• Christopher M Beausoleil, B.S.

  Bioscience of Bozeman LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 23, 2025
• Study Start: January 20, 2025
• Primary Completion: May 6, 2025
• Study Completion: June 11, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)