Artificial Intelligence (AI) Enabled, Cloud-based ECG Diagnostic Solution (ZBPro) Feasibility Testing
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
🗓️ Study Start (Actual) 30 August 2023
🗓️ Primary Completion (Estimated) May 2024
✅ Study Completion (Estimated) May 2024
👥 Enrollment (Estimated) 75
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Stony Brook, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Patients who are \> 18 years of age
    • 2. Patients who are from one of the clinical collaborators practices
    • 3. Patients who are prescribed to undergo ECG monitoring using an FDA-cleared monitoring device
    • 4. Patients who are post TAVR procedure, a recent history of stroke/TIA, or having cardiac related symptoms
    • 5. Patients who are comfortable using a smartphone or have someone in the home to help with data transmission
    • 6. Patients who have manual dexterity to be able to recharge the phone battery or someone in the home to help them
    • 7. Patients who are English speaking

    Exclusion Criteria:

    • 1. Patients who are \<18 years of age
    • 2. Patients who are not being prescribed with cardiac monitor testing
    • 3. Patients who refuse to sign informed consent
    • 4. Patients who are unable to provide informed consent
    • 5. Patients who have a pacemaker implanted
    • 6. Patients who are presenting with any dermatitis or infected skin over left anterior thorax
    • 7. Patients who have a history of reaction to a prior cardiac monitor device
    • 8. Patients who are uncomfortable having a cell phone at home for the duration of study participation
    • 9. Patients who non-English speaking
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 August 2023
  • First Submitted that Met QC Criteria 22 August 2023
  • First Posted 28 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 September 2023
  • Last Update Posted 26 September 2023
  • Last Verified September 2023