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NCT03719612 · ClinicalTrials.gov registry record · Phase 3
DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
A Phase 3 study, sponsored by Lantheus Medical Imaging.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
NCT03719612: Completed Phase 3 study, sponsored by Lantheus Medical Imaging.
NCT03719612 is a Phase 3 study that has completed, run by Lantheus Medical Imaging. The registered enrollment target is 160 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03719612, a Phase 3 study, has completed, sponsored by Lantheus Medical Imaging.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
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.
Primary Outcome
Demonstrate improvement in accuracy in left ventricular ejection fraction (LVEF) assessment using DEFINITY® contrast-enhanced over unenhanced echocardiography by comparing LVEF percentage differences from CMR measured by 3 independent blinded image readers.
Interventions
- DRUG DEFINITY®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2018-12-28 |
| Est. Completion | 2020-01-09 |
| Phase | Phase 3 |
What the finished NCT03719612 record still lists
NCT03719612 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which DEFINITY® is the first listed.
NCT03719612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03719612 about?
NCT03719612 is a clinical study titled "DEF-315 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 NCT03719612?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2018-12-28. Estimated completion is 2020-01-09.
What interventions are being tested in trial NCT03719612?
The interventions under investigation include: DEFINITY® (DRUG).
Who is sponsoring clinical trial NCT03719612?
This trial is sponsored by Lantheus Medical Imaging, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03719612's enrollment target sits among peer trials
160 1479th of 2000 higher than 500 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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