Aortic StenosisNCT04636892
Evaluating Infrasonic Hemodynography
A study testing MindMics earbud in people with Aortic Stenosis and Mitral Regurgitation, run by Scripps Health at 1 site in United States.
Trial summary
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension
- What is being tested?
- MindMics earbud
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Normal Sinus Rhythm
- LV systolic function >53%
Who cannot join
- 1. Known history of carotid artery disease
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Scripps Health
La Jolla, California, 92037
Curtiss Stinis, MD, stinis.curtiss@scrippshealth.org
Sanjeev Bhavnani, MD, bhavnani.sanjeev@scrippshealth.org
About this study
Official title: Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.
Read the detailed description
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system. 25 patients with cardiovascular disease will undergo a comprehensive echocardiogram, electrocardiogram, and cardiac catheterization while wearing a infrasonic earbud device. The infrasonic and hemodynamic waveforms will be analyzed using machine learning with the goal of correlating infrasound data captured by the earbud to the patient's cardiovascular hemodynamics.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, Heart Failure, Systolic, Cardiovascular Diseases, Coronary Artery Disease
- Being tested
- MindMics earbud
- Keywords
- infrasonic hemodynography, biomedical device
- Medical subject headings
- Aortic Valve Stenosis, Mitral Valve Insufficiency, Hypertension, Pulmonary, Heart Failure, Systolic, Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindMics earbudOther
Novel noninvasive wearable infrasound sensor
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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+ Receives: Other: MindMics earbud |
| Heart Failure with Reduced EF <35% | Experimental | Patients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35% Receives: Other: MindMics earbud |
| Pulmonary Hypertension | Experimental | Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg Receives: 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 Receives: Other: MindMics earbud |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infrasound Hemodynography
Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start4 Jan 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjeev Bhavnani MD, Scripps Health
- Investigators
- Sanjeev Bhavnani, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636892
- Sponsor's protocol ID
- 20-7677
- Status last verified
- Apr 2024
- First submitted
- 15 Nov 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography
- ClinicalTrials.gov ID
- NCT04636892
- Acronym / sponsor ID
- 20-7677
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, Heart Failure, Systolic, Cardiovascular Diseases, Coronary Artery Disease
- Keywords
- infrasonic hemodynography, biomedical device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.
Detailed description
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system. 25 patients with cardiovascular disease will undergo a comprehensive echocardiogram, electrocardiogram, and cardiac catheterization while wearing a infrasonic earbud device. The infrasonic and hemodynamic waveforms will be analyzed using machine learning with the goal of correlating infrasound data captured by the earbud to the patient's cardiovascular hemodynamics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Severe aortic stenosis | Experimental | Other: MindMics earbudPatients with echocardiographic evidence of severe aortic stenosis as defined by: Aortic Vmax ≥4 m/s or mean ΔP ≥40 mmHg AVA ≤1.0 cm2 |
| Severe mitral regurgitation | Experimental | Other: MindMics earbudPatients 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+ |
| Heart Failure with Reduced EF <35% | Experimental | Other: MindMics earbudPatients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35% |
| Pulmonary Hypertension | Experimental | Other: MindMics earbudPatients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg |
| Suspected coronary artery disease | Experimental | Other: MindMics earbudPatients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Normal Sinus Rhythm
- LV systolic function >53%
Key exclusion criteria (6 listed)
- 1. Known history of carotid artery disease
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindMics earbudNovel noninvasive wearable infrasound sensor | Other | Heart Failure with Reduced EF <35%, Pulmonary Hypertension, Severe aortic stenosis, Severe mitral regurgitation, Suspected coronary artery disease |
Primary outcome
Infrasound Hemodynography
Time frame: 1 year
Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Wearable PPG prediction of cardiac output from arterial line measurement in a swine modelLink provided by the sponsor.
- Hearables: Multimodal physiological in-ear sensingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjeev Bhavnani, MD principal investigator
Scripps Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindMics earbud in people with Aortic Stenosis and Mitral Regurgitation, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carly Waldman, MD (858-537-7792, waldman.carly@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infrasound Hemodynography (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.