Evaluating Infrasonic Hemodynography

NCT04636892 | Recruiting

• 1 other identifier: 20-7677
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

infrasonic hemodynography; biomedical device

Outcome Measures

Primary Outcomes (1)

• Infrasound Hemodynography

  Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals

  1 year

Study Arms (5)

Severe aortic stenosis

EXPERIMENTAL

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

Severe mitral regurgitation

EXPERIMENTAL

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

Heart Failure with Reduced EF <35%

EXPERIMENTAL

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

Other: MindMics earbud

Pulmonary Hypertension

EXPERIMENTAL

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

Other: MindMics earbud

Suspected coronary artery disease

EXPERIMENTAL

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

Other: MindMics earbud

Interventions

MindMics earbud OTHER

Novel noninvasive wearable infrasound sensor

Heart Failure with Reduced EF <35%; Pulmonary Hypertension; Severe aortic stenosis; Severe mitral regurgitation; Suspected coronary artery disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal Sinus Rhythm
• LV systolic function \>53%

You may not qualify if:

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

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Health

La Jolla, California, 92037, United States

RECRUITING

Related Links

• Wearable PPG prediction of cardiac output from arterial line measurement in a swine model
• Hearables: Multimodal physiological in-ear sensing

MeSH Terms

Conditions

Aortic Valve Stenosis; Mitral Valve Insufficiency; Hypertension, Pulmonary; Heart Failure, Systolic; Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Heart Failure; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Sanjeev Bhavnani, MD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carly Waldman, MD

CONTACT

858-537-7792; waldman.carly@scrippshealth.org

Sanjeev Bhavnani, MD

CONTACT

619-660-1842; bhavnani.sanjeev@scrippshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 19, 2020
• Study Start: January 4, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)