Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
NCT01242891 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2012-03-06
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.
Conditions
- Heart Failure
- Cardiomyopathies
Interventions
- DEVICE
-
EXCOR® Pediatric Ventricular Assist Device
Extracorporeal Ventricular Assist Device
Sponsors & Collaborators
-
Berlin Heart, Inc
lead INDUSTRY
Principal Investigators
-
All Previous IDE Sites · See IDE Clinical Trials Listing for IDE Study
Eligibility
- Min Age
- 1 Day
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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