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

NCT03719612 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-01-28

Study results available
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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

  • Cardiac Disease

Interventions

DRUG

DEFINITY®

All subjects will receive a single dose of DEFINITY®

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Lantheus Medical Imaging

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-28
Primary Completion
2020-01-09
Completion
2020-01-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03719612 on ClinicalTrials.gov