drugset / Trial / NCT03719612

DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

NCT03719612

Phase 3 Completed 160 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
2018-12-28
Primary completion
2020-01-09
Completion
2020-01-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Definity Diagnostic / imaging agent

Indications