Aortic Stenosis, Cardiovascular Diseases, Coronary Artery Disease, Heart Failure, Systolic, Mitral Regurgitation, Pulmonary Hypertension
Conditions
Keywords
infrasonic hemodynography, biomedical device
Brief summary
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.
Detailed description
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system. 25 patients with cardiovascular disease will undergo a comprehensive echocardiogram, electrocardiogram, and cardiac catheterization while wearing a infrasonic earbud device. The infrasonic and hemodynamic waveforms will be analyzed using machine learning with the goal of correlating infrasound data captured by the earbud to the patient's cardiovascular hemodynamics.
Interventions
OTHERMindMics earbud
Novel noninvasive wearable infrasound sensor
Sponsors
Scripps Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infrasound Hemodynography | 1 year | Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals |
Countries
United States
Contacts
Primary ContactCarly Waldman, MD
Backup ContactSanjeev Bhavnani, MD
Outcome results
None listed