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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03884504 | MDT-1118 Japan DT Study | PHASE3 | COMPLETED | 10 | — | — | May 1, 2019 | Oct 19, 2022 | Oct 21, 2022 | 1 | Japan |
Therapy will be considered a success if, at the end of 12 months in the study: 1. The subject is alive; and 2. The subject has not had a stroke of Modified Rankin Score ≥ 4; and 3. The subject retains the originally implanted device, unless the device was removed due to heart recovery, or the patient is electively transplanted. Therapy will be considered a failure if, within the 12 months in the study: 1. The subject dies; or 2. The subject has a stroke of Modified Rankin Score ≥ 4; or 3. The device malfunctions or fails, requiring exchange, explantation, or urgent transplantation.
| Name | Type | Description |
|---|---|---|
| Ventricular Assist Device System | DEVICE | Ventricular Assist Device System |
Inclusion Criteria: 1. Must be ≥20 years of age at consent 2. In judgment of body size, body surface area (BSA) and anatomy by Investigator, patient can be implanted MDT-1118 VAD. 3. Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following) ...