NCT04804969

Brief Summary

Clinical validation study of the MyoVista wavECG.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

March 16, 2021

Last Update Submit

September 20, 2023

Conditions

Cardiac Disease

Keywords

Left Ventricular Diastolic DysfunctionElectrocardiograph

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity

    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.

    Baseline

Secondary Outcomes (1)

  • Sensitivity and Specificity

    Baseline

Study Arms (1)

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

Interventions

MyoVista wavECG TestDEVICE

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.

At Risk Echo Referrals

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).
  • Subject is \>/= 22 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Heart DiseasesVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesVentricular Dysfunction

Study Officials

  • Partho Sengupta, MD

    Robert Wood Johnson University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 18, 2021

Study Start

May 10, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(5)