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

NCT07188129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-09-23

No results posted yet for this study

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

Interventions

DEVICE

Test Algorithm and Test Device

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

Sponsors & Collaborators

  • Zywie, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher M Beausoleil, B.S. · Bioscience of Bozeman LLC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-05-06
Completion
2025-06-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188129 on ClinicalTrials.gov