AI-enabled cloud ECG monitoring for heart conditions
Feasibility Testing of a Novel AI-enabled, Cloud-based ECG Diagnostic Solution to Enable Fast and Affordable Diagnosis in Long-term Continuous Ambulatory ECG Monitoring
This study is testing a new way to use a comfortable heart monitor that sends data to the cloud to help doctors quickly spot heart problems in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ZBeats INC Industry-sponsored |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT06013917 on ClinicalTrials.gov |
What this trial studies
This research focuses on improving the accessibility and affordability of long-term continuous electrocardiogram monitoring (LTCM) for detecting cardiac events. It utilizes a comfortable, FDA-cleared single-lead patch that transmits data to a cloud-based platform called ZBPro™, where proprietary AI algorithms analyze the data to identify arrhythmias and generate daily reports for physicians. The study aims to evaluate the feasibility of this innovative approach in real-world clinical settings, ensuring timely access to patient data for healthcare providers.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are prescribed ECG monitoring and have a history of cardiac symptoms or procedures.
Not a fit: Patients under 18, those without a prescription for cardiac monitoring, or individuals with certain medical conditions like pacemakers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the detection and management of cardiac conditions, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise with AI-driven cardiac monitoring solutions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stony Brook, New York
- Stony Brook University — Stony Brook, New York, United States (Recruiting)
Study contacts
- Principal investigator: Puja Parikh, MD — Stony Brook University
- Study coordinator: Bin Fang, PhD
- Email: bin.fang@zbeats.co
- Phone: 6312202463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.