Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03719612 | DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY | PHASE3 | COMPLETED | 160 | — | — | Dec 28, 2018 | Jan 9, 2020 | Jan 28, 2021 | 15 | United States |
| NCT03571672 | DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY | PHASE3 | COMPLETED | 153 | — | — | Oct 24, 2018 | Aug 30, 2019 | Dec 17, 2020 | 9 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| DEFINITY® | EXPERIMENTAL | Each patient will undergo an unenhanced ultrasound examination and a DEFINITY® contrast-enhanced ultrasound |
| DEFINITY | EXPERIMENTAL | Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound |
| Name | Type | Description |
|---|---|---|
| DEFINITY® | DRUG | All subjects will receive a single dose of DEFINITY® |
| DEFINITY | DRUG | All subjects will receive a single dose of DEFINITY® |
Inclusion Criteria: 1. Men and women ≥ 18 years of age in sinus rhythm 2. Able to communicate effectively with trial personnel 3. LVEF measurements obtained via 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0) 4. Has provided signed informed consent after receiv...