Evaluating Infrasonic Hemodynography
Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension
About this trial
This is an interventional diagnostic trial for Aortic Stenosis focused on measuring infrasonic hemodynography, biomedical device
Eligibility 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
Sites / Locations
- Scripps Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Severe aortic stenosis
Severe mitral regurgitation
Heart Failure with Reduced EF <35%
Pulmonary Hypertension
Suspected coronary artery disease
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
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+
Patients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35%
Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg
Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease