Pumps for Kids, Infants, and Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2023-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Pediatric Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Jarvik 2015

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Jarvik 2015 Device VAD

New, experimental continuous flow VAD

Group Type EXPERIMENTAL

Surgical placement of the Jarvik 2015 VAD

Intervention Type DEVICE

The Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device.

Surgical Placement of Jarvik 2015 VAD

Intervention Type PROCEDURE

Surgical Implant of the Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device.

Interventions

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Surgical placement of the Jarvik 2015 VAD

The Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device.

Intervention Type DEVICE

Surgical Placement of Jarvik 2015 VAD

Surgical Implant of the Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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%

Eligible Sex

ALL

Accepts Healthy Volunteers

No