Pumps for Kids, Infants, and Neonates

Inclusion Criteria

All children with severe (Ross or New York Heart Association (NYHA) class IV) heart failure
despite optimal medical therapy (INTERMACS profiles for pediatrics: Profiles 1 or 2) who
require mechanical circulatory support and meet the following criteria:

1. Males and females within weight range: 8.0 Kg ≤ weight ≤ 30.0 Kg

2. Males and females within Body surface area (BSA) range: 0.4 m2 ≤ BSA ≤ 1.0 m2

3. Cardiac anatomy categories:

1. Standard Cardiac Anatomy: Two-ventricle circulation, including cardiomyopathy,
repaired structural heart disease (e.g. anomalous left coronary artery from the
pulmonary artery [ALCAPA], aortic stenosis) or acquired heart disease (e.g.,
myocarditis, Kawasaki disease)

2. Challenging Cardiac Anatomy: Any challenging cardiac anatomy (including but not
limited to single ventricle heart disease, RCM, HCM3-5) that, in the opinion of
the investigator with confirmation from the PumpKIN Executive Committee, is
difficult to support with available (e.g. pulsatile) devices.

4. INTERMACS Profile 1 or 2 as evidenced by:

1. Inability to wean from extra-corporeal membrane oxygenation (ECMO) or other
temporary circulatory support (TCS), OR

2. Inability to wean from mechanical ventilator support, OR

3. Inotrope-dependent, decompensated heart failure AND meet one or more of the
following criteria within 48 hours prior to implant (unless otherwise noted)
which is attributed to decompensated heart failure despite optimal medical
therapy:

i. Urine output <0.5 cc/kg/hour for 12hr within 48 hours ii. Creatinine level >2 times
the upper limit of normal (ULN) for age iii. Alanine aminotransferase (ALT) or total
bilirubin result >3 times the ULN for age (either qualifies the patient) iv. Mixed
venous oxygen saturation (SvO2) <55% (or arteriovenous oxygen different >45%) in two
repeated measurements v. Acidosis: Base excess >-5 in 2 or more measurements vi.
Inability to tolerate appropriate enteral calories as prescribed by a registered
dietician vii. Inability to ambulate freely to participate fully in age-appropriate
activities of daily living (ADLs) and/or cardiac rehabilitation/physical therapy, OR

5. Potentially eligible (i.e., no medical or surgical contraindications) to be listed for
cardiac transplant, United Network for Organ Sharing status 1A, or equivalent

6. Written consent of parent(s) or legally authorized representative (LAR) where
appropriate.

Exclusion Criteria

To be eligible for this trial, the subjects must meet none of the following exclusion
criteria at the time of enrollment or between the enrollment and device implant:

1. Known contraindication to systemic anticoagulation

2. Currently participating in an interventional trial whose protocol prevents effective
application of the Jarvik 2015 device, potentially has an independent effect on trial
endpoints, or otherwise interferes with execution of the PumpKIN protocol

3. Stable inotrope dependence (INTERMACS profile 3)

4. Single ventricle anatomy prior to stage II surgical palliation (i.e. prior to superior
cavo-pulmonary anastomosis, also known as a Glenn or hemi-Fontan) or Fontan surgery

5. Presence of a mechanical heart valve

6. Unresolved malignancy

7. CPR with duration > 30 consecutive minutes within 48 hours prior to device implant or
CPR with uncertain neurological status prior to device implant

8. Renal dysfunction that is severe or, in the opinion of the investigator, irreversible

9. Hepatic dysfunction that is severe or, in the opinion of the investigator,
irreversible

10. Severe or irreversible pulmonary dysfunction

11. ECMO use for > 10 consecutive days

12. Unrepairable severe aortic insufficiency

13. Active, systemic infection unresponsive to antimicrobials therapy

14. Known cerebrovascular event within the past 30 days or uncertain neurological status

15. Severe right ventricular (RV) dysfunction or significant arrhythmia requiring
treatment with an RV assist device (RVAD) (i.e., biventricular assist device)

16. Unmanageable bleeding per judgment of the investigator