Evaluation of a Test Algorithm for Use to Analyze ECG Data Collected From a Test Device of a 24-h… (NCT07188129) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Test Algorithm for Use to Analyze ECG Data Collected From a Test Device of a 24-hour Simulated Use Period
United States153 participantsStarted 2025-01-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 participatin…
What they're measuring
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
Timeframe: 24 Hours after Application of Test Device