Brief Title
Evaluating Infrasonic Hemodynography
Official Title
Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography
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.
Study Type
Interventional
Primary Outcome
Infrasound Hemodynography
Condition
Aortic Stenosis
Intervention
MindMics earbud
Study Arms / Comparison Groups
Severe aortic stenosis
Description: Patients with echocardiographic evidence of severe aortic stenosis as defined by: Aortic Vmax ≥4 m/s or mean ΔP ≥40 mmHg AVA ≤1.0 cm2
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
25
Start Date
January 1, 2021
Completion Date
December 31, 2021
Primary Completion Date
June 1, 2021
Eligibility 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Sanjeev Bhavnani, MD, 858-537-7792, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04636892
Organization ID
20-7677
Responsible Party
Principal Investigator
Study Sponsor
Scripps Health
Collaborators
Rajbir Sidhu MD, Principal Co-Investigator
Study Sponsor
Sanjeev Bhavnani, MD, Principal Investigator, Scripps Health
Verification Date
December 2020