Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Scripps Health
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Infrasound Hemodynography
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Sanjeev Bhavnani MD
Principal Investigator
Scripps Health
Eligibility Criteria
Inclusion Criteria
- •Normal Sinus Rhythm
- •LV systolic function \>53%
Exclusion Criteria
- •Known history of carotid artery disease
- •Moderate or greater valvular disease in Group 1
- •Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc)
- •Active arrhythmia
- •Reduced Ejection Fraction (\< 35%) other than Group 4
- •Hearing loss
Outcomes
Primary Outcomes
Infrasound Hemodynography
Time Frame: 1 year
Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals