Pumps for Kids, Infants, and Neonates (PumpKIN)

Carelon Research

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Pediatric Heart Failure

Treatments: Procedure: Surgical Placement of Jarvik 2015 VAD; Device: Surgical placement of the Jarvik 2015 VAD

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02954497

C01367

Details and patient eligibility

About

PumpKIN is a multicenter, prospective, single-arm feasibility study; Evaluating the investigational Jarvik 2015 VAD in pediatric patients with heart failure. This feasibility trial will enroll 10 subjects at up to 7 sites in the US.

The primary objectives of this investigational device exemption (IDE) clinical investigation are to assess the feasibility of using the Jarvik 2015 in pediatric patients with severe heart failure who require mechanical circulatory support. Feasibility will be assessed by evaluating the safety profile of the Jarvik 2015 device in eligible subjects.

Enrollment: 7 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Children must meet all of the following criteria:

1. Males and females within weight range 8 to 30 kg

2. Body surface area (BSA) 0.4 m2 to 1.0 m2

3. Cardiac Diagnosis:

   a. 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)

4. INTERMACS Profile 1 or 2 as evidenced by one or more of the following:

   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 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 difference of >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 d. Inability to ambulate freely to participate fully in age-appropriate activities of daily living (ADLs) and/or cardiac rehabilitation/physical therapy

5. LVAD support is intended for bridge-to transplant. Subject is listed for transplant or eligible (i.e., no medical or surgical contraindications) to be listed for cardiac transplant, United Network for Organ Sharing (UNOS) status 1A, or equivalent

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

Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:

1. Known contraindication for systemic anticoagulation
2. Currently participating in an interventional trial whose protocol prevents effective application of Jarvik 2015, 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
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 antimicrobial 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
17. Ventricular dysfunction that is likely to recover (e.g. myocarditis, metabolic myopathy where LV dysfunction is present solely with intermittent acidosis/crises).
18. Left ventricular end-diastolic dimension or left ventricular end-diastolic volume z score of < +2.5 end-diastolic dimension or ventricular end-diastolic volume z score of < +3.0
19. Left ventricular ejection fraction of >35%

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Jarvik 2015 Device VAD

Experimental group

Description:

New, experimental continuous flow VAD

Treatment:

Device: Surgical placement of the Jarvik 2015 VAD

Procedure: Surgical Placement of Jarvik 2015 VAD