Berlin Heart EXCOR Pediatric VAD, Manual, Page: 40 / 250

Chapter 3 Summary of Clinical Studies
Exclusion Criteria
1. Support on ECMO for
≥
10 days
2. Cardiopulmonary resuscitation (CPR) duration
≥
30 minutes within 48 hours prior
to device implantation
3. Body weight < 3.0 kg or BSA > 1.5 m 2
4. Presence of mechanical aortic valve
5. Unfavorable or technically-challenging cardiac anatomy including single ventricle
lesions, complex heterotaxy, and restrictive cardiomyopathy
6. Evidence of intrinsic hepatic disease as defined by a total bilirubin level or AST/
ALT greater than five times the upper limit of normal for age, except in association
with acute heart failure as determined by the principal investigator
7. Evidence of intrinsic renal disease as defined by a serum creatinine greater than
3 times the upper limit of normal for age, except in association with acute heart
failure as determined by the principal investigator
8. Hemodialysis or peritoneal dialysis (not including dialysis or Continuous Veno-
Venous Hemofiltration (CVVH) for volume removal
9. Evidence of intrinsic pulmonary disease (e.g. chronic lung disease, RDS) as
defined by need for chronic mechanical ventilation, except in association with
acute heart failure as determined by the principal investigator
10. Moderate or severe aortic and/or pulmonic valve insufficiency considered
technically challenging to repair at the time of the device implantation as
determined by the principal investigator
11. Apical VSD or other hemodynamically-significant lesion considered technically
challenging to repair at the time of device implantation as determined by the
principal investigator
12. Documented heparin induced thrombocytopenia (HIT) or idiopathic
thrombocytopenia purpura (ITP) or other contraindication to anticoagulant/
antiplatelet therapy
13. Documented coagulopathy (e.g. Factor VIII deficiency, disseminated
intravascular coagulation) or thrombophilic disorder (e.g. Factor V Leiden
mutation)
14. Hematologic disorder causing fragility of blood cells or hemolysis (e.g. sickle cell
disease)
15. Active infection within 48 hours of implant demonstrated by:
a. Positive blood culture OR
b. Temperature >38 degrees C and WBC >15, 000/ ml
16. Documented human immunodeficiency virus (HIV) infection or acquired
immunodeficiency syndrome (AIDS)
17. Evidence of recent or life-limiting malignant disease
18. Stroke within past 30 days prior to enrollment, or congenital CNS malformation
syndrome associated with increased risk of bleeding (e.g. arteriovenous
malformation, moya moya)
19. Psychiatric or behavioral disease (e.g. antisocial disorder) with a high likelihood
for non-compliance
20. Currently participating in another investigational device or drug trial and has not
completed the required follow-up period for that study
21. Subject is pregnant or nursing
3.6.4 Study Enrollment
The following table summarizes the complete enrollment (including the subjects
enrolled at non IDE sites) by subject’s body size. As of the data cutoff for the final HDE
report (February 2011 report with January 17, 2011 data cutoff), there were 151
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