Evaluating Infrasonic Hemodynography | NCT04636892 | Trialant

Evaluating Infrasonic Hemodynography | NCT04636892 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Severe aortic stenosis	Experimental	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	Other: MindMics earbud
Severe mitral regurgitation	Experimental	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+	Other: MindMics earbud
Heart Failure with Reduced EF <35%	Experimental	Patients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35%	Other: MindMics earbud
Pulmonary Hypertension	Experimental	Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg	Other: MindMics earbud
Suspected coronary artery disease	Experimental	Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MindMics earbud	Other	Novel noninvasive wearable infrasound sensor	Heart Failure with Reduced EF <35% Pulmonary Hypertension Severe aortic stenosis

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