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Evaluating Infrasonic Hemodynography

Primary Purpose

Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MindMics earbud
Sponsored by
Scripps Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Stenosis focused on measuring infrasonic hemodynography, biomedical device

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Severe aortic stenosis

Severe mitral regurgitation

Heart Failure with Reduced EF <35%

Pulmonary Hypertension

Suspected coronary artery disease

Arm Description

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

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+

Patients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35%

Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg

Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease

Outcomes

Primary Outcome Measures

Infrasound Hemodynography
Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals

Secondary Outcome Measures

Full Information

First Posted
November 15, 2020
Last Updated
March 15, 2021
Sponsor
Scripps Health
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1. Study Identification

Unique Protocol Identification Number
NCT04636892
Brief Title
Evaluating Infrasonic Hemodynography
Official Title
Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, Heart Failure, Systolic, Cardiovascular Diseases, Coronary Artery Disease
Keywords
infrasonic hemodynography, biomedical device

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Severe aortic stenosis
Arm Type
Experimental
Arm Description
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
Arm Title
Severe mitral regurgitation
Arm Type
Experimental
Arm Description
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+
Arm Title
Heart Failure with Reduced EF <35%
Arm Type
Experimental
Arm Description
Patients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35%
Arm Title
Pulmonary Hypertension
Arm Type
Experimental
Arm Description
Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg
Arm Title
Suspected coronary artery disease
Arm Type
Experimental
Arm Description
Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease
Intervention Type
Other
Intervention Name(s)
MindMics earbud
Intervention Description
Novel noninvasive wearable infrasound sensor
Primary Outcome Measure Information:
Title
Infrasound Hemodynography
Description
Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Bhavnani, MD
Organizational Affiliation
Scripps Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.nature.com/articles/s41598-020-74686-6
Description
Wearable PPG prediction of cardiac output from arterial line measurement in a swine model
URL
https://pubmed.ncbi.nlm.nih.gov/28761162/
Description
Hearables: Multimodal physiological in-ear sensing

Learn more about this trial

Evaluating Infrasonic Hemodynography

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