Evaluating Infrasonic Hemodynography

Scripps Health

Status: Enrolling

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

Treatments: Other: MindMics earbud

Study type: Interventional

Funder types: Other

Identifiers

NCT04636892

20-7677

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 5 patient groups

Severe aortic stenosis

Experimental group

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

Treatment:

Other: MindMics earbud

Severe mitral regurgitation

Experimental group

Description:

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+

Treatment:

Other: MindMics earbud

Heart Failure with Reduced EF <35%

Experimental group

Description:

Patients with echocardiographic evidence of left ventricular ejection fraction of \< or = to 35%

Treatment:

Other: MindMics earbud

Pulmonary Hypertension

Experimental group

Description:

Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) \>20mmHg

Treatment:

Other: MindMics earbud

Suspected coronary artery disease

Experimental group

Description:

Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease

Treatment:

Other: MindMics earbud