Evaluating Infrasonic Hemodynography

Sponsor

Scripps Health (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04636892

Collaborator

(none)

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis Mitral Regurgitation Pulmonary Hypertension Heart Failure, Systolic Cardiovascular Diseases Coronary Artery Disease	Other: MindMics earbud	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 4, 2021

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Severe aortic stenosis 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 Novel noninvasive wearable infrasound sensor
Experimental: Severe mitral regurgitation 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 Novel noninvasive wearable infrasound sensor
Experimental: Heart Failure with Reduced EF <35% Patients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35%	Other: MindMics earbud Novel noninvasive wearable infrasound sensor
Experimental: Pulmonary Hypertension Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg	Other: MindMics earbud Novel noninvasive wearable infrasound sensor
Experimental: Suspected coronary artery disease Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease	Other: MindMics earbud Novel noninvasive wearable infrasound sensor

Outcome Measures

Primary Outcome Measures

Infrasound Hemodynography [1 year]
Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Normal Sinus Rhythm
LV systolic function >53%

Exclusion Criteria:

1. Known history of carotid artery disease
1. Moderate or greater valvular disease in Group 1
1. Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc)
1. Active arrhythmia
1. Reduced Ejection Fraction (< 35%) other than Group 4
1. Hearing loss