NCT04066634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

July 25, 2019

Last Update Submit

July 28, 2021

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Primary Endpoint - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System

    Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System compared to the Expert Physician Panel (EPP).

    48 Hours

Secondary Outcomes (4)

  • Secondary Endpoint 1 - Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.

    48 Hours

  • Secondary Endpoint 2 - Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography.

    48 Hours

  • Secondary Endpoint 3 - Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV).

    48 Hours

  • Secondary Endpoint 4 - Assessment of type and degree of all heart sounds associated with aortic stenosis (mild/moderate/severe).

    48 Hours

Other Outcomes (1)

  • Ancillary Endpoint - Incidence of Adverse Events

    48 Hours

Study Arms (1)

Assist in Diagnosis

EXPERIMENTAL

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.

Device: Vivio System

Interventions

Vivio SystemDEVICE

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.

Also known as: Electronic stethoscope
Assist in Diagnosis

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Sean Brady, JD

    Avicena LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2019

First Posted

August 26, 2019

Study Start

April 2, 2019

Primary Completion

October 29, 2019

Study Completion

October 29, 2019

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations

US(3)