At a glance
ClinicalIndex Comparison RecordN/ACompleted· 48 enrolled
Drug / intervention
EXCOR Pediatricdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-center, Single Arm Study to Access the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device [EXCOR Pediatric]
In Brief
A clinical study evaluating EXCOR Pediatric for Heart Failure and Cardiomyopathies. Completed, enrolled 48 participants across 17 sites in 2 countries.
Detailed Summary
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and Drug Administration under a Humanitarian Device Exception (HDE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Cardiomyopathies
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedDec 2007
Primary CompletionSep 2010
Study CompletionDec 2011
TodayJul 2026
First PostedDec 31, 2007
Enrollment StartMay 1, 2007
Primary CompletionSep 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.5 years ago
Interventions
EXCOR Pediatricdevice
Extracorporeal Ventricular Assist Device