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MindMics earbud for Mitral Valve Regurgitation

Q: What is the current number of individuals receiving medical care as part of this clinical trial?

<p>Indeed, data from clinicaltrials.gov highlights the ongoing recruitment efforts for this research investigation. The trial was first listed on January 4th, 2021, and last modified on April 15th, 2024. Enrollment aims to reach a total of 25 participants across one designated location.</p>

Q: Is the current investigation open for participant enrollment?

<p>Indeed, the details on clinicaltrials.gov indicate that this medical research endeavor is actively seeking suitable individuals. The trial was initially disclosed on January 4th of the year 2021 and underwent its most recent revision on April 15th, 2024. A total of 25 potential candidates are being sought at a single designated site.</p>

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Infrasound Hemodynography

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%

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Scripps HealthLead Sponsor

55 Previous Clinical Trials

43,436 Total Patients Enrolled

Sanjeev Bhavnani, MDPrincipal InvestigatorScripps Health

4 Previous Clinical Trials

26,095 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals receiving medical care as part of this clinical trial?

"Indeed, data from clinicaltrials.gov highlights the ongoing recruitment efforts for this research investigation. The trial was first listed on January 4th, 2021, and last modified on April 15th, 2024. Enrollment aims to reach a total of 25 participants across one designated location."

Answered by AI

Is the current investigation open for participant enrollment?

"Indeed, the details on clinicaltrials.gov indicate that this medical research endeavor is actively seeking suitable individuals. The trial was initially disclosed on January 4th of the year 2021 and underwent its most recent revision on April 15th, 2024. A total of 25 potential candidates are being sought at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating Infrasonic Hemodynography

Sanjeev Bhavnani MD 2021. "Evaluating Infrasonic Hemodynography". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04636892.

All > Aortic Stenosis > Pulmonary Hypertension