Evaluating Infrasonic Hemodynography

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography

Conditions
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Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, Heart Failure, Systolic, Cardiovascular Diseases, Coronary Artery Disease

Intervention / Treatment
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* Other: MindMics earbud


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe aortic stenosis<br>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 | Other: MindMics earbud<br>* Novel noninvasive wearable infrasound sensor<br>|
| Experimental: Severe mitral regurgitation<br>Patients with echocardiographic evidence of severe mitral regurgitation as defined by: Central jet MR >40% LA or holosystolic eccentric jet MR Vena contracta ≥0.7 cm Regurgitant volume ≥60 mL Regurgitant fraction ≥50% ERO ≥0.40 cm2 Angiographic grade 3 to 4+ | Other: MindMics earbud<br>* Novel noninvasive wearable infrasound sensor<br>|
| Experimental: Heart Failure with Reduced EF <35%<br>Patients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35% | Other: MindMics earbud<br>* Novel noninvasive wearable infrasound sensor<br>|
| Experimental: Pulmonary Hypertension<br>Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg | Other: MindMics earbud<br>* Novel noninvasive wearable infrasound sensor<br>|
| Experimental: Suspected coronary artery disease<br>Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease | Other: MindMics earbud<br>* Novel noninvasive wearable infrasound sensor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infrasound Hemodynography | Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infrasonic hemodynography, biomedical device