Evaluating Infrasonic Hemodynography

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Aortic Stenosis; Mitral Regurgitation; Pulmonary Hypertension; Heart Failure, Systolic
• Intervention / Treatment: Other: MindMics earbud

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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carly Waldman, MD; Phone Number: 858-537-7792; Email: waldman.carly@scrippshealth.org
• Study Contact Backup: Name: Sanjeev Bhavnani, MD; Phone Number: 619-660-1842; Email: bhavnani.sanjeev@scrippshealth.org

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Scripps Health
      • Contact: Curtiss Stinis, MD; Email: stinis.curtiss@scrippshealth.org
      • Contact: Sanjeev Bhavnani, MD; Email: bhavnani.sanjeev@scrippshealth.org
      • Principal Investigator: Steven Romero, MD
      • Sub-Investigator: Sanjeev Bhavnani, MD
      • Principal Investigator: Curtis Stinnis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infrasound Hemodynography	Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals	1 year

Collaborators and Investigators

• Sponsor: Scripps Health
• Investigators: Principal Investigator: Sanjeev Bhavnani, MD, Scripps Health

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: November 15, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: infrasonic hemodynography; biomedical device
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lung Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Hypertension; Heart Failure; Coronary Artery Disease; Cardiovascular Diseases; Aortic Valve Stenosis; Mitral Valve Insufficiency; Hypertension, Pulmonary; Heart Failure, Systolic
• Other Study ID Numbers: 20-7677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No