Evaluating Infrasonic Hemodynography

Not Applicable

Recruiting

• Conditions: Aortic Stenosis; Cardiovascular Diseases; Heart Failure, Systolic; Mitral Regurgitation; Coronary Artery Disease; Pulmonary Hypertension
• Interventions: Other: MindMics earbud

• Registration Number: NCT04636892
• Lead Sponsor: Scripps Health

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 Timeline

• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-11-15
• Study First Posted: 2020-11-19
• Study Start: 2021-01-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heart Failure with Reduced EF <35%	MindMics earbud	Patients with echocardiographic evidence of left ventricular ejection fraction of \< or = to 35%
Severe aortic stenosis	MindMics earbud	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
Severe mitral regurgitation	MindMics earbud	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+
Suspected coronary artery disease	MindMics earbud	Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease
Pulmonary Hypertension	MindMics earbud	Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) \>20mmHg

Primary Outcome Measures

Name	Time	Method
Infrasound Hemodynography	1 year	Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals

Trial Locations

Locations (1)

Scripps Health; 🇺🇸 La Jolla, California, United States