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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
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%
Find a Location
Who is running the clinical trial?
Scripps HealthLead Sponsor
58 Previous Clinical Trials
43,548 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
2,325 Patients Enrolled for Coronary Artery Disease
Sanjeev Bhavnani, MDPrincipal InvestigatorScripps Health
4 Previous Clinical Trials
26,095 Total Patients Enrolled