NCT03702192

EXCOR® Pediatric VAD Anticoagulation IDE

EXCOR® Pediatric VAD Anticoagulation IDE Investigational Plan

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: David N. Rosenthal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric HD

Interventions

Type	Name	Description
DEVICE	novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR	novel antithrombotic management protocol

Timeline

• Start date: 2018-11-01
• Primary completion: 2018-11-01
• Completion: 2019-01-17
• First posted: 2018-10-10
• Last updated: 2019-10-31

Regulatory

• FDA-regulated device study