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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03719612

Public ClinicalTrials.gov record NCT03719612. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Open-Label, Multicenter Trial to Evaluate Ejection Fraction, End-Diastolic and End-Systolic Volumes, by Unenhanced and DEFINITY®-Enhanced 2D-Echo and Magnetic Resonance Imaging

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03719612
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Lantheus Medical Imaging
Industry
Enrollment
160 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 27, 2018
Primary completion
Jan 8, 2020
Completion
Jan 8, 2020
Last update posted
Jan 27, 2021

2018 – 2020

United States locations

U.S. sites
15
U.S. states
13
U.S. cities
15
Facility City State ZIP Site status
Banner University of Arizona Medical Center Tucson Arizona 85724
Cedars Sinai Los Angeles California 90048
University of California-Irvine Orange California 92868
UC San Diego San Diego California 92037
Alfieri Cardiology Wilmington Delaware 19803
Northwestern Medical Group Chicago Illinois 60611
Indiana University Bloomington Indiana 46202
Baptist Hospital Paducah Kentucky 42003
Mercy Unit Hospital Coon Rapids Minnesota 55433
Duke University Medical Center Durham North Carolina 27710
University of Cincinnati Medical Center Cincinnati Ohio 45219
University of Oklahoma Oklahoma City Oklahoma 73104
Oregon Health and Sciences University Portland Oregon 97240
Albert Einstein Medical Center Philadelphia Pennsylvania 19412
Baylor Scott White Research Institute Temple Texas 76501

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03719612, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 27, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03719612 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →