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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
Sponsor:
Information provided by (Responsible Party):
David N. Rosenthal, Stanford University

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 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Severe heart failure (NYHA functional class IV, or Ross functional class IV if < age 6 years of age), refractory to optimal medical therapy
  2. Patient deemed to be candidate for EXCOR implantation according to the clinical criteria employed by treating site
  3. Listed or eligible for cardiac transplantation according to the criteria employed by the treating site
  4. Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease, or acquired heart disease
  5. Age 0 to 18 years of age
  6. Corrected gestational age ≥ 37 weeks
  7. Weight ≥ 3 kg and ≤ 60 kg
  8. Legal guardian (and patient if age-appropriate) understands the nature of the investigation, is willing to comply with the protocol and associated evaluations, and provides written informed consent and assent prior to the procedure.

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 m2
  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 ALT greater than 5 times the upper limit of normal for age, except in association with acute heart failure as determined by the site 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 investigator
  8. Hemodialysis or peritoneal dialysis (not including dialysis or continuous veno-venous hemofiltration (CVVH) for volume removal)
  9. Evidence of intrinsic pulmonary disease (eg chronic lung disease, or ARDS) as defined by need for positive pressure ventilation, except in association with acute heart failure as determined by the principal investigator
  10. Moderate or severe aortic and/or pulmonary 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. Platelets < 70,000/ml within 24 hours prior to device implantation
  16. Active infection within 48 hours of implant (positive blood culture OR temperature > 38 degrees C AND wbc > 15,000/ml)
  17. Documented human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
  18. Evidence of recent or life-limiting malignant disease
  19. 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)
  20. Psychiatric or behavioral disease (e.g. antisocial disorder) with a high likelihood for non-adherence to the protocol and follow-up
  21. Currently participating in another investigational device or drug trial and has not completed the required follow-up period for that study. EXCEPTION: Dual enrollment in PUMPKIN study is permitted.
  22. Patient is pregnant or nursing


Responsible Party: David N. Rosenthal, Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT03702192     History of Changes
Other Study ID Numbers: IRB-47736
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by David N. Rosenthal, Stanford University:
heart failure