Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04804969
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Heart Test Laboratories, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Clinical validation study of the MyoVista wavECG.

Condition or disease Intervention/treatment
Cardiac Disease Device: MyoVista wavECG Test

Detailed Description:

This is a multi-center, non-interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. Study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram.

The study will be conducted at a minimum of three investigational sites within the United States.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 575 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MyoVista wavECG Clinical Validation Study
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
At Risk Echo Referrals
Study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram as standard of care. All will receive a MyoVista wavECG test.
 Device: MyoVista wavECG Test
The MyoVista wavECG is a standard 12-Lead high-performance, multi-channel resting interpretive electrocardiograph providing both a Glasgow Interpretive Analysis and unique MyoVista wavECG Information.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: Baseline ]
    Sensitivity and specificity of the MyoVista for the classification of Low e' from echocardiogram where a "positive" includes Positive and Highly Positive MyoVista Device outcomes.


Secondary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: Baseline ]
    Sensitivity and specificity of the MyoVista for classification of Low e' versus echocardiogram where a "positive" includes Borderline, Positive and Highly Positive MyoVista Device outcomes.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment and have been referred to the site for 2D transthoracic echocardiogram.
Criteria

Inclusion Criteria:

  • Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment.
  • The subject provides written informed consent using an Informed Consent Form that is reviewed and approved by the site's Institutional Review Board (IRB).
  • Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below).
  • Subject is >/= 22 years of age

Exclusion Criteria:

  • The subject has current acute coronary syndrome, decompensated heart failure or stroke
  • The subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (CABG), heart transplant, ablation, coronary stent placement, etc.
  • Conventional ECG results indicating a lack of sinus rhythm and/or any other contraindicated rhythm abnormalities, including: active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block
  • The subject is pregnant at the time of the study testing
  • The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)
  • Subjects with central nervous system or musculoskeletal abnormalities that may interfere with accurate acquisition of ECG and/or echocardiogram measurements.
  • The subject is enrolled in another clinical study that may interfere with MyoVista or echocardiogram measurements. Exceptions to this may be approved by HeartSciences.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04804969


Contacts
Layout table for location contacts
Contact: Carol Krieger 973-747-7816 carol.krieger@heartsciences.com
Contact: Mark Hilz 214-763-8480 mark.hilz@heartsciences.com

Locations
Layout table for location information
United States, California
Scripps Memorial Hospital Recruiting
La Jolla, California, United States, 92037
Contact: Mollie R. Paster, CCRP    858-824-4248    paster.mollie@scrippshealth.org   
Principal Investigator: Sanjeev Bhavnani, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Elizabeth Roe    617-632-7652    eroe@bidmc.harvard.edu   
Principal Investigator: Jordan Strom, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Jose Matias, MD    718-920-6442    jmatias@montefiore.org   
Principal Investigator: Jorge Romero, MD         
United States, Pennsylvania
Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Christiana Carns, MS    215-456-7316    carnschr@einstein.edu   
Principal Investigator: Gregg S. Pressman, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75204
Contact: Bienka Lewis, MD    214-648-2091    Bienka.Milton@UTSouthwestern.edu   
Principal Investigator: Ambarish Pandey, MD         
Sponsors and Collaborators
Heart Test Laboratories, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Partho Sengupta, MD Robert Wood Johnson University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Heart Test Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT04804969    
Other Study ID Numbers: HS-CLINVAL-001
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Heart Test Laboratories, Inc.:
Left Ventricular Diastolic Dysfunction
Electrocardiograph
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases