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Evaluating Infrasonic Hemodynography

Evaluating Infrasonic Hemodynography

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Phase N/A

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Overview

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.

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.

Eligibility

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

NCT04636892

Scripps Health

30 April 2024

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