Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03719612
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2018-09-28
Brief Title:
DEF-315 Better Accuracy in Ejection Fraction EF Assessment With DEFINITY
Sponsor:
Lantheus Medical Imaging
Organization:
Lantheus Medical Imaging
Study Overview
Official Title:
A Phase III Open-Label Multicenter Trial to Evaluate Ejection Fraction End-Diastolic and End-Systolic Volumes by Unenhanced and DEFINITY-Enhanced 2D-Echo and Magnetic Resonance Imaging
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
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:
BENEFIT2
Brief Summary:
This is a Phase 3 prospective open-label multicenter study to evaluate Left Ventricular Ejection Fraction LVEF measurement accuracy and reproducibility of DEFINITY contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging CMR used as the truth standard
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None