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Vivio AS (Aortic Stenosis) Detection Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066634
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Avicena LLC

Brief Summary:
Evaluate the sensitivity and specificity of the Vivio System when used as an aid in the identification of heart sounds associated with severe aortic stenosis.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Device: Vivio System Not Applicable

Detailed Description:
Prospective, non-randomized, multi-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 3 sites. Up to 10 roll-in subjects per site. Enrolled subjects will undergo: Vivio data capture, Eko stethoscope capture of heart sounds, Standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel. Recorded sounds from the FDA-approved Eko stethoscope will be presented to an independent expert physician review panel blinded to Vivio and TTE results, to compare diagnosis of severe AS using Eko (auscultation) vs. Vivio (algorithms).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of the Vivio System as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
Actual Study Start Date : April 2, 2019
Actual Primary Completion Date : October 29, 2019
Actual Study Completion Date : October 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Device: Vivio System
The Vivio Analysis Software is an analysis software that assists in identifying suspected systolic murmurs associated with aortic stenosis. The Vivio Analysis Software is used with the Vivio System, a non-invasive device used for the detection and amplification of sounds from the heart and arteries.




Primary Outcome Measures :
  1. Primary Endpoint - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System [ Time Frame: 48 Hours ]
    Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System compared to the Expert Physician Panel (EPP).


Secondary Outcome Measures :
  1. Secondary Endpoint 1 - Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis. [ Time Frame: 48 Hours ]
    Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.

  2. Secondary Endpoint 2 - Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography. [ Time Frame: 48 Hours ]
    Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography.

  3. Secondary Endpoint 3 - Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV). [ Time Frame: 48 Hours ]
    Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV).

  4. Secondary Endpoint 4 - Assessment of type and degree of all heart sounds associated with aortic stenosis (mild/moderate/severe). [ Time Frame: 48 Hours ]
    Assessment of type and degree of all heart sounds associated with aortic stenosis (mild/moderate/severe). The heart sounds associated with severe aortic stenosis using a traditional electronic stethoscope include S1 (normal), S2 (single or paradoxically split) and a late peaking (mid to late systole) diamond shaped, grade 3 or higher murmur. The Vivio system can detect a single component of S2 (aortic) over the carotid but not the pulmonic component or splitting characteristics. It can also detect the nature and timing of the systolic murmur as transmitted through the vascular system to the carotid. The heart sounds associated with severe aortic stenosis include S1 (normal), presence or absence of S2. Less severe aortic stenosis is characterized by an early to mid-peaking diamond shape murmur with a soft but present aortic component of S2.


Other Outcome Measures:
  1. Ancillary Endpoint - Incidence of Adverse Events [ Time Frame: 48 Hours ]
    Incidence of Adverse Events: Summary of all reported adverse events during the study. Events will be summarized by seriousness (e.g. serious vs. non-serious), attribution (e.g. device vs. procedure vs. comorbidity) based upon site reported data.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult subjects (21 years of age or older).
  2. Referred for transthoracic echocardiography by physician/primary care provider/cardiologist.
  3. Willing and able to participate in all study evaluations and allow access to medical testing and records.
  4. Signed informed consent or have a legally authorized representative who provides informed consent on behalf of the subject.

Exclusion Criteria:

  1. Acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical circulatory support.
  2. Need for bedside echocardiogram (inpatient).
  3. Prosthetic device previously implanted at aortic valve position.
  4. Inability to palpate carotid pulse (e.g. due to severe obesity)
  5. History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).
  6. History of carotid artery disease or treatment (e.g. unstable carotid plaques that might rupture upon massage or endarterectomy).
  7. Open skin lesions at target site of electronic stethoscope/Vivio device examination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066634


Locations
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United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07960
United States, New York
St. Francis Hospital
Roslyn, New York, United States, 11576
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Avicena LLC
Investigators
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Study Director: Marie Csete, MD, PhD Avicena LLC
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Responsible Party: Avicena LLC
ClinicalTrials.gov Identifier: NCT04066634    
Other Study ID Numbers: VS-001-AS
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction