Trials / Approved For Marketing
Approved For MarketingNCT01242891
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
A Prospective, Multi-center, Single Arm Study to Assess the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (EXCOR® Pediatric)Under a Continued Access Protocol.
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Berlin Heart, Inc · Industry
- Sex
- All
- Age
- 1 Day – 16 Years
- Healthy volunteers
- —
Summary
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.
Detailed description
The data collection and protocols for this study remain consistent with the main IDE study for the EXCOR® Pediatric Ventricular Assist Device. This protocol was closed at the same time as the main IDE study due to FDA approval (December 16, 2011).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EXCOR® Pediatric Ventricular Assist Device | Extracorporeal Ventricular Assist Device |
Timeline
- First posted
- 2010-11-17
- Last updated
- 2012-03-06
Source: ClinicalTrials.gov record NCT01242891. Inclusion in this directory is not an endorsement.