Evaluating Infrasonic Hemodynography

Not Applicable

Recruiting

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

• 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

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