Recruiting

Infrasonic Hemodynography

Sponsor:

Scripps Health

Code:

NCT04636892

Conditions

Aortic Stenosis

Mitral Regurgitation

Pulmonary Hypertension

Heart Failure, Systolic

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

MindMics earbud

Study Details

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

Study ID

NCT04636892

Start date

Jan 4, 2021

Status verified date

Apr, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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+

experimental: Heart Failure with Reduced EF <35%

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

experimental: Pulmonary Hypertension

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

experimental: Suspected coronary artery disease

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

Interventions

MindMics earbud

Novel noninvasive wearable infrasound sensor

Primary outcome measure

  • Infrasound Hemodynography [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Carly Waldman, MD

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

Sanjeev Bhavnani, MD

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

Locations

Scripps Health

Recruiting

La Jolla, California, United States, 92037

Contacts

Curtiss Stinis, MD

stinis.curtiss@scrippshealth.org

Sanjeev Bhavnani, MD

bhavnani.sanjeev@scrippshealth.org

Principal Investigator:

Steven Romero, MD

More Information

Sponsor

Scripps Health

Last update posted

Apr 16, 2024

Last verified

Apr, 2024

Keywords

  • infrasonic hemodynography
  • biomedical device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Health on 2024-04-16.