DEF-314 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
- 2018-10-24
- Primary completion
- 2019-08-30
- Completion
- 2019-08-30
Outcome
Missed primary endpoint
registry analysis (superiority test); Blinded Reader 1; p = 0.868; Mean Difference (Final Values) -0.08; t-test, 2 sided NCT03571672 ↗
registry analysis (superiority test); Blinded Reader 2; p = 0.606; Mean Difference (Final Values) -0.23; t-test, 2 sided NCT03571672 ↗
registry analysis (superiority test); Blinded Reader 3; p = 0.224; Mean Difference (Final Values) -0.43; t-test, 2 sided NCT03571672 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Definity | Diagnostic / imaging agent | — | — |