- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04636892
Evaluating Infrasonic Hemodynography
March 15, 2021 updated by: Sanjeev Bhavnani MD, Scripps Health
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Scripps Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Normal Sinus Rhythm
- LV systolic function >53%
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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 |
Novel noninvasive wearable infrasound sensor
|
EXPERIMENTAL: Severe mitral regurgitation
Patients with echocardiographic evidence of severe mitral regurgitation as defined by:
|
Novel noninvasive wearable infrasound sensor
|
EXPERIMENTAL: Heart Failure with Reduced EF <35%
Patients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35%
|
Novel noninvasive wearable infrasound sensor
|
EXPERIMENTAL: Pulmonary Hypertension
Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg
|
Novel noninvasive wearable infrasound sensor
|
EXPERIMENTAL: Suspected coronary artery disease
Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease
|
Novel noninvasive wearable infrasound sensor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infrasound Hemodynography
Time Frame: 1 year
|
Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanjeev Bhavnani, MD, Scripps Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 4, 2021
Primary Completion (ANTICIPATED)
June 1, 2021
Study Completion (ANTICIPATED)
December 31, 2021
Study Registration Dates
First Submitted
November 15, 2020
First Submitted That Met QC Criteria
November 15, 2020
First Posted (ACTUAL)
November 19, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 15, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Lung Diseases
- Aortic Valve Disease
- Heart Valve Diseases
- Ventricular Outflow Obstruction
- Coronary Disease
- Hypertension
- Heart Failure
- Coronary Artery Disease
- Cardiovascular Diseases
- Aortic Valve Stenosis
- Mitral Valve Insufficiency
- Hypertension, Pulmonary
- Heart Failure, Systolic
Other Study ID Numbers
- 20-7677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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