Trials / Completed
CompletedNCT03719612
DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Lantheus Medical Imaging · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DEFINITY® | All subjects will receive a single dose of DEFINITY® |
Timeline
- Start date
- 2018-12-28
- Primary completion
- 2020-01-09
- Completion
- 2020-01-09
- First posted
- 2018-10-25
- Last updated
- 2021-01-28
- Results posted
- 2021-01-07
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03719612. Inclusion in this directory is not an endorsement.