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

Completed · Not applicable

Conditions studied: Atrial Fibrillation (AF), Tachycardia, Bradycardia, PVC - Premature Ventricular Contraction, Premature Atrial Contraction

In brief

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.

Key facts

Study ID

NCT07188129

Run by

Zywie, Inc.

People needed

153

Starts

2025-01-20

Expected to finish

2025-06-11

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Bioscience of Bozeman, LLC — Bozeman, Montana, United States

Full record on ClinicalTrials.gov

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