Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-20 @ 1:35 PM
Study NCT ID:
NCT03702192
Status:
WITHDRAWN
Last Update Posted:
2019-10-31
First Post:
2018-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXCOR® Pediatric VAD Anticoagulation IDE
Sponsor:
David N. Rosenthal
Organization:
Study Overview
Official Title:
EXCOR® Pediatric VAD Anticoagulation IDE Investigational Plan
Status:
WITHDRAWN
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI withdrew protocol
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Berlin Heart EXCOR ventricular assist device received approval from the FDA as a bridge to transplantation for children in 2011. Successful bridge to transplantation or recovery in the IDE trial of the Berlin Heart EXCOR was 88% to 92%, but a high incidence of neurological injury was reported in this trial (29%).
Stroke remains the most important complication of Berlin Heart EXCOR support, with high mortality rates, and considerable long-term morbidity. The EXCOR IDE study incorporated a novel anticoagulation protocol (henceforth referred to as the Edmonton Anticoagulation Protocol). The preponderance of ischemic strokes in this study raised the question of whether the anticoagulation protocol was sufficiently intensive, as ischemic strokes in this setting are virtually always thromboembolic phenomena. In response to these data and to the experience at the investigator's institution, a novel anticoagulation protocol has been devised for use with the EXCOR (Stanford anticoagulation protocol).The purpose of this study is to perform a pilot evaluation of this protocol in a multi--center setting, to prepare for a randomized trial between this and a subsequent iteration of anticoagulation treatment.
Stroke remains the most important complication of Berlin Heart EXCOR support, with high mortality rates, and considerable long-term morbidity. The EXCOR IDE study incorporated a novel anticoagulation protocol (henceforth referred to as the Edmonton Anticoagulation Protocol). The preponderance of ischemic strokes in this study raised the question of whether the anticoagulation protocol was sufficiently intensive, as ischemic strokes in this setting are virtually always thromboembolic phenomena. In response to these data and to the experience at the investigator's institution, a novel anticoagulation protocol has been devised for use with the EXCOR (Stanford anticoagulation protocol).The purpose of this study is to perform a pilot evaluation of this protocol in a multi--center setting, to prepare for a randomized trial between this and a subsequent iteration of anticoagulation treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: