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MindMics Earbud for Heart Conditions

N/A

Recruiting

Led By Sanjeev Bhavnani, MD

Research Sponsored by Scripps Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new wearable device that can detect how well your heart is working without needing to go through any invasive procedures.

Who is the study for?

This trial is for people with certain heart conditions like mitral valve regurgitation, various types of pulmonary hypertension, aortic valve stenosis, coronary artery disease, and heart failure. Participants should have a normal heartbeat rhythm and good left ventricle pumping function.

What is being tested?

The study is testing the MindMics earbud's ability to noninvasively monitor the mechanical, electrical, and blood flow functions of the heart by comparing its accuracy with other diagnostic methods.

What are the potential side effects?

Since this trial involves a noninvasive wearable device (MindMics earbud), there are no direct side effects from medication or invasive procedures expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infrasound Hemodynography

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Suspected coronary artery diseaseExperimental Treatment1 Intervention

Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease

Group II: Severe mitral regurgitationExperimental Treatment1 Intervention

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+

Group III: Severe aortic stenosisExperimental Treatment1 Intervention

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

Group IV: Pulmonary HypertensionExperimental Treatment1 Intervention

Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) \>20mmHg

Group V: Heart Failure with Reduced EF <35%Experimental Treatment1 Intervention

Patients with echocardiographic evidence of left ventricular ejection fraction of \< or = to 35%

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