DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
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.
Timeline
- Start
- 2018-12-28
- Primary completion
- 2020-01-09
- Completion
- 2020-01-09
Outcome
Missed primary endpoint
registry analysis (superiority test); Blinded Reader 1; p = 0.358; Mean Difference (Final Values) -0.38; t-test, 2 sided NCT03719612 ↗
registry analysis (superiority test); Blinded Reader 2; p = 0.804; Mean Difference (Final Values) -0.12; t-test, 2 sided NCT03719612 ↗
registry analysis (superiority test); Blinded Reader 3; p = 0.371; Mean Difference (Final Values) -0.33; t-test, 2 sided NCT03719612 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Definity | Diagnostic / imaging agent | — | — |