N/A
N=48
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
Heart Failure · Cardiomyopathies
Bottom Line
View on ClinicalTrials.gov: NCT00583661 ↗Enrolled (actual)
48
Serious AEs
85.4%
Results posted
Mar 2013
Primary outcome: Primary: The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device. — 0.068; 0.066 Events per patient-day — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EXCOR Pediatric (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Berlin Heart, Inc
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device. |
0.068; 0.066 | <0.05 sig |
| PRIMARY Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device. |
21; 22 | — |
Summary
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and Drug Administration under a Humanitarian Device Exception (HDE).
Eligibility Criteria
Inclusion Criteria
- Severe New York Heart Association (NYHA) Functional Class IV (or Ross Functional Class IV for patients = 3 kg and = 10 days
- Cardiopulmonary resuscitation (CPR) duration >= 30 minutes within 48 hours of implantation
- Body weight 1.5 m2
- Presence of mechanical aortic valve
- Unfavorable or technically-challenging cardiac anatomy including single ventricle lesions, complex heterotaxy, and restrictive cardiomyopathy
- Evidence of intrinsic hepatic disease
- Evidence of intrinsic renal disease
- Evidence of intrinsic pulmonary disease
- Hemodialysis or peritoneal dialysis (not including dialysis or continuous veno-venous hemofiltration (CVVH) for fluid removal)
- Moderate or severe aortic and/or pulmonic valve insufficiency
- Apical Ventricular Septal Defects (VSD) or other compromise that is technically challenging to repair at implant
- Documented heparin induced thrombocytopenia (HIT)
- Documented coagulopathy
- Hematologic disorder
- Active Infection within 48 hours of implant (positive blood culture or White Blood Cell Count >15,000 and fever > 38 degrees C)
- Documented Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
- Evidence of recent life-limiting malignant disease
- Stroke within 30 days prior to enrollment
- Psychiatric or behavioral disease
- Currently participating in another Investigational Device Exemption (IDE) or Investigational New Drug Application (IND) trial
- Patient is pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT00583661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.