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Artificial Intelligence (AI) Enabled, Cloud-based ECG Diagnostic Solution (ZBPro) Feasibility Testing

NCT06013917 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2023-09-26

No results posted yet for this study

Summary

The proposed research is to address the accessibility and affordability of technology to capture symptomatic and asymptomatic cardiac events via Long-Term Continuous Electrocardiogram Monitoring (LTCM), and to provide physicians with full access to their patients' recorded data in a timely manner. We adopt an FDA cleared single- lead OEM patch Holter made of flexible material to make long-term wearing more comfortable and more patient compliant. The patch transmits the recorded data to our cloud-based platform: ZBPro™, where our innovative technologies reside. Our proprietary AI algorithms with innovative human interaction tools, which were developed under the National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase I (Award #: 2025951) Award analyze and interpret the recorded data to detect and annotate arrhythmia/cardiac events, and generates daily reports for physician review. The feasibility of our algorithms has been verified using ZBeats' proprietary ECG database based on the standard ANSI/AAMI EC57. Data collection and transmission has been verified in the office environment.

This proposed observational study will utilize a multidisciplinary collaboration of ZBeats Inc. (ZBTS), Stony Brook University (SBU), and Lankenau Medical Center (LMC). The study will enroll patients undergoing ECG monitoring. The primary outcome measure will be the ability to capture cardiac arrhythmias and events from participants. The prescribed FDA-cleared device will serve as the ground truth (GT) for our analyses. The detected arrhythmias and events from our solution will be compared with the findings from the ground truth to obtain our system's detection rate. The goal is to achieve a detection rate of \>80% to be deemed successful.

Conditions

  • Arrhythmias, Cardiac

Interventions

DEVICE

Cardiac Monitoring

FDA cleared ECG monitoring device that will be used to obtain ECG recordings and capture cardiac arrhythmias/events from participants

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Stony Brook University

    collaborator OTHER

  • Main Line Health

    collaborator OTHER

  • ZBeats INC

    lead INDUSTRY

Principal Investigators

  • Puja Parikh, MD · Stony Brook University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2024-05-31
Completion
2024-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06013917 on ClinicalTrials.gov