NCT07188129

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

Assessing Compatibility of the ZywieAI Algorithm to Analyze ECG Data Collected From the Zywiez3 Sensor and Adhesive Over a 24-hour Period

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Zywie, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Test Algorithm and Test Device	Test Algorithm analysis of 24-hour ECG Data collected with a Test Device

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-05-06
• Completion: 2025-06-11
• First posted: 2025-09-23
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study