Evaluating a wearable device for cardiovascular function monitoring
Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography
This study is testing a new wearable device that monitors heart function in people with cardiovascular diseases to see how accurately it works compared to standard heart tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Sex | All |
| Sponsor | Scripps Health Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04636892 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the accuracy of a noninvasive wearable infrasonic sensor designed to monitor the mechanical, electrical, and hemodynamic functions of the cardiovascular system. A total of 25 patients with cardiovascular diseases will participate, undergoing comprehensive echocardiograms, electrocardiograms, and cardiac catheterizations while wearing the infrasonic earbud device. The data collected will be analyzed using machine learning techniques to correlate the infrasound data with the patients' cardiovascular hemodynamics.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with cardiovascular diseases who have normal sinus rhythm and preserved left ventricular systolic function.
Not a fit: Patients with significant valvular disease, active arrhythmias, or those with hearing loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a new, noninvasive method for monitoring cardiovascular health in patients.
How similar studies have performed: While the approach of using infrasonic sensors is innovative, similar studies have shown promise in noninvasive cardiovascular monitoring techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Normal Sinus Rhythm * LV systolic function \>53% Exclusion Criteria: * 1. Known history of carotid artery disease * 2. Moderate or greater valvular disease in Group 1 * 3. Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc) * 4. Active arrhythmia * 5. Reduced Ejection Fraction (\< 35%) other than Group 4 * 6. Hearing loss
Where this trial is running
La Jolla, California
- Scripps Health — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Sanjeev Bhavnani, MD — Scripps Health
- Study coordinator: Carly Waldman, MD
- Email: waldman.carly@scrippshealth.org
- Phone: 858-537-7792
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.