Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Normal Sinus Rhythm
• LV systolic function \>53%
Locations
United States
California
Scripps Health
RECRUITING
La Jolla
Contact Information
Primary
Carly Waldman, MD
waldman.carly@scrippshealth.org
858-537-7792
Backup
Sanjeev Bhavnani, MD
bhavnani.sanjeev@scrippshealth.org
619-660-1842
Time Frame
Start Date: 2021-01-04
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 25
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Scripps Health