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出境医 / 临床实验 / Rapid Non-invasive Detection of Aortic Stenosis

Rapid Non-invasive Detection of Aortic Stenosis

Study Description
Brief Summary:
Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Aortic stenosis (AS) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. When AS is severe, the heart cannot pump adequate amounts of blood into the arterial tree. AS is often silent until the disease is severe. This study compares a rapid test using Vivio to a longer and more expensive test that is the current gold standard for diagnosis of AS, TTE.

Condition or disease Intervention/treatment
Heart Valve Diseases Aortic Valve Disease Heart Murmurs Device: Vivio System

Detailed Description:

The study proposed here is a research study to develop the Vivio system for diagnosis of severe AS. The data gathered in this study will be used to optimize the Avicena software algorithm used to make the diagnosis of AS.

The Vivio device is an optical-type tonometer that operates based on capturing the vibrations of the skin due to the arterial pulse pressure wave as it propagates through the underlying carotid vessel. When applied to the neck over the subject's carotid pulse, an arterial waveform (pressure tracing) and heart sounds are sensed, and sent to an iPad using Bluetooth, then sent to Avicena for analysis.

After informed consent subjects will undergo a brief cardiac-focused history and examination. All subjects will have bilateral exams with the Vivio (~5 minutes each) conducted by a study doctor or nurse, and a standard clinical resting TTE conducted by a certified technician. The entire study visit should take 1.5 hours, and there is no follow up.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Aortic Stenosis Screening Using the Avicena Vivio System
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Optimized algorithm for diagnosis of AS [ Time Frame: 2 years ]
    Data collected in this study will be analyzed by multiple mathematical approaches to develop an optimized algorithm for detection of severe AS


Secondary Outcome Measures :
  1. Positive predictive value (PPV) of Vivio in the diagnosis of severe AS [ Time Frame: 2 years ]
    PPV for detecting AS by Vivio compared to PPV for 2D TTE


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date July 16, 2019
First Posted Date July 18, 2019
Last Update Posted Date August 6, 2020
Actual Study Start Date August 14, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019) 		Optimized algorithm for diagnosis of AS [ Time Frame: 2 years ]
Data collected in this study will be analyzed by multiple mathematical approaches to develop an optimized algorithm for detection of severe AS
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2019) 		Positive predictive value (PPV) of Vivio in the diagnosis of severe AS [ Time Frame: 2 years ]
PPV for detecting AS by Vivio compared to PPV for 2D TTE
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rapid Non-invasive Detection of Aortic Stenosis
Official Title Aortic Stenosis Screening Using the Avicena Vivio System
Brief Summary Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Aortic stenosis (AS) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. When AS is severe, the heart cannot pump adequate amounts of blood into the arterial tree. AS is often silent until the disease is severe. This study compares a rapid test using Vivio to a longer and more expensive test that is the current gold standard for diagnosis of AS, TTE.
Detailed Description

The study proposed here is a research study to develop the Vivio system for diagnosis of severe AS. The data gathered in this study will be used to optimize the Avicena software algorithm used to make the diagnosis of AS.

The Vivio device is an optical-type tonometer that operates based on capturing the vibrations of the skin due to the arterial pulse pressure wave as it propagates through the underlying carotid vessel. When applied to the neck over the subject's carotid pulse, an arterial waveform (pressure tracing) and heart sounds are sensed, and sent to an iPad using Bluetooth, then sent to Avicena for analysis.

After informed consent subjects will undergo a brief cardiac-focused history and examination. All subjects will have bilateral exams with the Vivio (~5 minutes each) conducted by a study doctor or nurse, and a standard clinical resting TTE conducted by a certified technician. The entire study visit should take 1.5 hours, and there is no follow up.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Severe, symptomatic AS incidence increases with age, so that most patients do not experience symptoms until after age 60. For this reason, to enrich for the population of patients with potential AS, subjects over age 65 will be studied.
Condition
  • Heart Valve Diseases
  • Aortic Valve Disease
  • Heart Murmurs
Intervention Device: Vivio System
Optical/sensor tonometer applied to the neck over the carotid pulse (bilateral)
Study Groups/Cohorts Not Provided
Publications * Ahmed AK, Garberich R, Gossl M, Tindell L, Williams K, Dennis S, Bae R, Soraja P. A novel method of non-invasive screening for patients with aortic stenosis. JACC March 12, 2019, 73 (9 Supplement 1) 1995; DOI:10.1016/S0735-1097(19)32601-4

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 16, 2019) 		400
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Adult subjects >60 years of age
  2. Ability to understand and sign informed consent
  3. Willingness to undergo study protocol (in Pasadena CA)

Exclusion Criteria:

  1. Inability to provide informed consent
  2. History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck)
  3. History of significant or symptomatic carotid artery disease, or carotid artery stenting or surgery
  4. History of aortic valve surgery or transcatheter aortic valve replacement
  5. Absent carotid pulse on initial examination (inability to palpate the carotid pulse)
  6. Open skin lesions at the site of Vivio application/examination
  7. Presence of a carotid bruit on examination
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Dave Silvey 626-255-3917 dave@avicenaheart.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024566
Other Study ID Numbers AS20192
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Avicena LLC
Study Sponsor Avicena LLC
Collaborators Not Provided
Investigators
Study Director: Sean Brady, JD Chief Executive Officer
PRS Account Avicena LLC
Verification Date August 2020

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