MyoVista wavECG Clinical Validation Study
Status: Active_not_recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
Clinical validation study of the MyoVista wavECG.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Scripps Memorial Hospital
La Jolla
Massachusetts
Beth Israel Deaconess Medical Center
Boston
New York
Montefiore Medical Center
Bronx
Pennsylvania
Einstein Medical Center
Philadelphia
Texas
University of Texas Southwestern Medical Center
Dallas
Time Frame
Start Date: 2021-05-10
Completion Date: 2023-11-30
Participants
Target number of participants: 575
Treatments
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.
Authors
Sponsors
Leads: Heart Test Laboratories, Inc.