Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2013
• Main ID: NCT00583661
• Date of registration: 20/12/2007
• Primary sponsor: Berlin Heart, Inc
• Public title: Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
• Scientific title: A Prospective, Multi-center, Single Arm Study to Access the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device [EXCOR Pediatric]
• Date of first enrolment: May 2007
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00583661
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

• Name: Charles D Fraser, MD, FACS
• Affiliation: Texas Children's Hospital / Baylor College of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Severe New York Heart Association (NYHA) Functional Class IV (or Ross Functional Class
IV for patients <= 6 years) heart failure refractory to optimal medical therapy, and has
met at least one of the following criteria:

- Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)
profile status 1 or 1a, i.e. critical cardiogenic shock (low BP unresponsive to
support), compromised end organ perfusion, < 24 hour survival without mechanical
support; may be due to Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF)
(1A) OR

- INTERMACS profile status or 2A (i.e progressive decline): not in imminent danger,
but worsening despite optimal inotropic therapy; may be due to VT/VF (2A) AND at
least one of the following criteria: Decline in renal functions, Decline in
nutritional status, Decline in mobility/ambulation

OR

- Support with extra-corporeal membrane oxygenation (ECMO) or other mechanical
circulatory support device OR

- Unable to separate from cardiopulmonary bypass

- Listed (UNOS status 1A or equivalent) for cardiac transplantation

- Two-ventricle circulation, including cardiomypathy, repaired structural heart
disease or acquired heart disease

- Age 0 to 16 years

- Weight >= 3 kg and <= 60 kg

- Legal guardian (and patient if age-appropriate) understands the nature of the
procedure, is willing to comply with associated follow-up evaluations, and
provide written informed consent and assent prior to the procedure

Exclusion Criteria:

- Support on ECMO for >= 10 days

- Cardiopulmonary resuscitation (CPR) duration >= 30 minutes within 48 hours of
implantation

- Body weight < 3.0 kg or Body Surface Area > 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



Age minimum: N/A
Age maximum: 16 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiomyopathies

Heart Failure

Intervention(s)

Device: EXCOR Pediatric

Primary Outcome(s)

Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device. [Time Frame: Participants were followed while on device support, an average of 58 days]

The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device. [Time Frame: Participants were followed while on device support, an average of 58 days]

Secondary ID(s)

EXCOR® Pediatric

Source(s) of Monetary Support

Please refer to primary and secondary sponsors