Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-29 @ 7:52 AM
Study NCT ID:
NCT04804969
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2021-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram
Sponsor:
Heart Test Laboratories, Inc.
Organization:
Study Overview
Official Title:
MyoVista wavECG Clinical Validation Study
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinical validation study of the MyoVista wavECG.
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.
The study will be conducted at a minimum of three investigational sites within the United States.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: