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DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
NCT03571672 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03571672
The ClinicalTrials.gov registry entry for NCT03571672 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lantheus Medical Imaging, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03571672 reports 9 study locations spanning 9 distinct geographic areas — top geographies include Arizona, California, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03571672?
The interventions under investigation include: DEFINITY (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03571672?
This trial is sponsored by Lantheus Medical Imaging, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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