EXCOR® Pediatric VAD Anticoagulation IDE
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|ClinicalTrials.gov Identifier: NCT03702192|
Recruitment Status : Not yet recruiting
First Posted : October 10, 2018
Last Update Posted : October 10, 2018
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 our institutional experience, we have devised a novel anticoagulation protocol 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.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric HD||Device: novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||EXCOR® Pediatric VAD Anticoagulation IDE Investigational Plan|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2022|
Experimental: single-arm novel anticoagulation
Single-arm clinical study to assess the safety, and effectiveness of a novel anticoagulation protocol to be used in conjunction with the Berlin Heart EXCOR Pediatric Ventricular Assist Device as a bridge to heart transplantation in children with severe heart failure who have failed optimal medical therapy.
Device: novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR
novel antithrombotic management protocol
- Number of major bleeding adverse events reported using the Stanford Anti-Thrombotic Protocol. [ Time Frame: Up to 90 days ]To test the safety of the Stanford Anti-Thrombotic Protocol.
- Number of all forms of stroke events reported using the Stanford Anti-Thrombotic Protocol. [ Time Frame: Up 90 days ]To test the effectiveness of the Stanford Anti-Thrombotic protocol.