Status:
UNKNOWN
Artificial Intelligence (AI) Enabled, Cloud-based ECG Diagnostic Solution (ZBPro) Feasibility Testing
Lead Sponsor:
ZBeats INC
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Stony Brook University
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Patients who are \> 18 years of age
- Patients who are from one of the clinical collaborators practices
- Patients who are prescribed to undergo ECG monitoring using an FDA-cleared monitoring device
- Patients who are post TAVR procedure, a recent history of stroke/TIA, or having cardiac related symptoms
- Patients who are comfortable using a smartphone or have someone in the home to help with data transmission
- Patients who have manual dexterity to be able to recharge the phone battery or someone in the home to help them
- Patients who are English speaking
Exclusion
- Patients who are \<18 years of age
- Patients who are not being prescribed with cardiac monitor testing
- Patients who refuse to sign informed consent
- Patients who are unable to provide informed consent
- Patients who have a pacemaker implanted
- Patients who are presenting with any dermatitis or infected skin over left anterior thorax
- Patients who have a history of reaction to a prior cardiac monitor device
- Patients who are uncomfortable having a cell phone at home for the duration of study participation
- Patients who non-English speaking
Key Trial Info
Start Date :
August 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06013917
Start Date
August 30 2023
End Date
May 1 2024
Last Update
September 26 2023
Active Locations (1)
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1
Stony Brook University
Stony Brook, New York, United States, 11794