Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2021-01-04
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Severe aortic stenosis
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
MindMics earbud
Novel noninvasive wearable infrasound sensor
Severe mitral regurgitation
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+
MindMics earbud
Novel noninvasive wearable infrasound sensor
Heart Failure with Reduced EF <35%
Patients with echocardiographic evidence of left ventricular ejection fraction of \< or = to 35%
MindMics earbud
Novel noninvasive wearable infrasound sensor
Pulmonary Hypertension
Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) \>20mmHg
MindMics earbud
Novel noninvasive wearable infrasound sensor
Suspected coronary artery disease
Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease
MindMics earbud
Novel noninvasive wearable infrasound sensor
Interventions
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MindMics earbud
Novel noninvasive wearable infrasound sensor
Eligibility Criteria
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Inclusion Criteria
* LV systolic function \>53%
Exclusion Criteria
* 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
ALL
No
Sponsors
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Scripps Health
OTHER
Responsible Party
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Sanjeev Bhavnani MD
Principal Investigator
Principal Investigators
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Sanjeev Bhavnani, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Health
Locations
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Scripps Health
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Wearable PPG prediction of cardiac output from arterial line measurement in a swine model
Hearables: Multimodal physiological in-ear sensing
Other Identifiers
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20-7677
Identifier Type: -
Identifier Source: org_study_id
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