Trials / Completed
CompletedNCT04634708
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 24 (actual)
- Sponsor
- Berlin Heart GmbH · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.
Detailed description
The study has a prospective, multicenter, international, single arm, observational design. Study enrollment is expected to take 18 months and subjects will be followed until they reach an outcome or for 45 days on the EXCOR Active driving unit. The overall study duration is expected to be approximately 20 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | No intervention due to observational design |
Timeline
- Start date
- 2020-11-01
- Primary completion
- 2022-09-15
- Completion
- 2022-09-15
- First posted
- 2020-11-18
- Last updated
- 2023-05-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04634708. Inclusion in this directory is not an endorsement.