Clinical Trials

Evaluating Infrasonic Hemodynography

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04636892
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Scripps Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sanjeev Bhavnani, MD
Principal Investigator Affiliation	Scripps Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, Heart Failure, Systolic, Cardiovascular Diseases, Coronary Artery Disease
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

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

Other: - MindMics earbud

Novel noninvasive wearable infrasound sensor

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Scripps Health, La Jolla, California

Status

Recruiting

Address

Scripps Health

La Jolla, California, 92037

Site Contact

Curtiss Stinis, MD

stinis.curtiss@scrippshealth.org

858-537-7792