drugset / Trial / NCT03571672

DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

NCT03571672

Phase 3 Completed 153 enrolled Lantheus Medical Imaging Syneos Health · collab
NaSingle-groupOpen-labelDiagnostic

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Definity Diagnostic / imaging agent

Indications