Status:
COMPLETED
Evaluation of a Test Algorithm for Use to Analyze ECG Data Collected From a Test Device of a 24-hour Simulated Use Period
Lead Sponsor:
Zywie, Inc.
Conditions:
Atrial Fibrillation (AF)
Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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 simula...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2025
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT07188129
Start Date
January 20 2025
End Date
June 11 2025
Last Update
September 23 2025
Active Locations (1)
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1
Bioscience of Bozeman, LLC
Bozeman, Montana, United States, 59715