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NCT03571672 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Cardiac Disease, sponsored by Lantheus Medical Imaging.

Completed
Registry status
Phase 3
Development phase
153
Enrollment target
9
Study locations

NCT03571672 is a Phase 3 study of Cardiac Disease that has completed, run by Lantheus Medical Imaging. The registered enrollment target is 153 participants, below the 816-participant average among 24 other Cardiac Disease trials with a reported enrollment target (81% lower). The trial reports 9 study locations across 9 states.

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The verdict

NCT03571672, a Phase 3 study of Cardiac Disease, has completed, sponsored by Lantheus Medical Imaging.

COMPLETED
Registry status
Phase 3
Development phase
153 participants
Enrollment target
9
Study locations

Study 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 Studied

Interventions

  • DRUG DEFINITY

Study Locations (9)

Arizona

  • Banner University of Arizona Medical Center - Tucson

California

  • University of California-San Diego - San Diego

Delaware

  • Alfieri Cardiology - Wilmington

Michigan

  • Henry Ford Hospital - Detroit

New York

  • Weill Cornell Medical Center - New York

North Carolina

  • Duke University - Durham

Ohio

  • University Hospital/Cleveland Medical Center - Cleveland

Pennsylvania

  • Thomas Jefferson University - Philadelphia

Trial Details

FieldValue
Enrollment Target 153 participants
Start Date 2018-10-24
Est. Completion 2019-08-30
Phase Phase 3

Sponsor

Lantheus Medical Imaging

22 total trials

What the Registry Record Tells You About NCT03571672

The ClinicalTrials.gov registry entry for NCT03571672 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 816-participant average among 24 other Cardiac Disease trials with a reported enrollment target (81% lower). The listed sponsor is Lantheus Medical Imaging, which has 22 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cardiac Disease appearing as the primary indexed condition, and to 1 intervention - of which DEFINITY is the first listed.

NCT03571672 reports 9 study locations spanning 9 distinct geographic areas - top geographies include Arizona, California, Delaware.

Frequently Asked Questions

What is clinical trial NCT03571672 about?

NCT03571672 is a clinical study titled "DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY". 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 t...

What is the current status of trial NCT03571672?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2018-10-24. Estimated completion is 2019-08-30.

What conditions does trial NCT03571672 study?

This clinical trial studies the following conditions: Cardiac Disease.

What interventions are being tested in trial NCT03571672?

The interventions under investigation include: DEFINITY (DRUG).

Who is sponsoring clinical trial NCT03571672?

This trial is sponsored by Lantheus Medical Imaging, which has 22 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03571672 being conducted?

This trial has 9 study locations across Arizona, California, Delaware, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.