Suspended

PumpKINJarvik 2015 VAD for Pediatric Heart Failure

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Study Aim

This early phase 1 study aims to evaluate the safety and clinical feasibility of the Jarvik 2015 VAD device in pediatric patients with heart failure, by assessing serious adverse events and survival rates up to 30 days of support or until heart transplant or recovery.

What is being tested

Surgical placement of the Jarvik 2015 VAD

+ Surgical Placement of Jarvik 2015 VAD

DeviceProcedure
Who is being recruted

Congenital Abnormalities+4

+ Cardiovascular Diseases

+ Heart Defects, Congenital

+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Device Feasibility Study

Early Phase 1
Interventional
Study Start: October 2018
See protocol details

Summary

Principal SponsorCarelon Research
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 22, 2018

Actual date on which the first participant was enrolled.

The PumpKIN study focuses on evaluating the use of an investigational device, the Jarvik 2015 VAD, in children with severe heart failure who need mechanical circulatory support. This early-stage trial aims to enroll 10 pediatric patients across up to 7 sites in the US. The main goal is to assess the feasibility of using the Jarvik 2015 in these young patients, which could potentially improve their heart function and quality of life. During the study, participants will use the Jarvik 2015 device, and the safety of the device will be evaluated by monitoring for any serious adverse events. The study also aims to assess the clinical feasibility of the device by looking at survival rates and the absence of severe neurological impairment or device failure. Additionally, the study will explore technical, surgical, and clinical milestones to understand the overall feasibility of the device. The findings from this study will help inform the design of future trials.

Official TitlePumps for Kids, Infants, and Neonates
NCT02954497
Principal SponsorCarelon Research
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Device Feasibility Study

These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCardiovascular DiseasesHeart Defects, CongenitalHeart DiseasesHeart FailureCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiovascular Abnormalities

Criteria

19 exclusion criteria prevent from participating
Presence of a mechanical heart valve
Unresolved malignancy
Known contraindication for systemic anticoagulation
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
New, experimental continuous flow VAD

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Lucile Packard Children's Hospital Stanford

Palo Alto, United StatesOpen Lucile Packard Children's Hospital Stanford in Google Maps
Suspended

Children's Healthcare of Atlanta

Atlanta, United States
Suspended

Boston Children's Hospital

Boston, United States
Suspended

Columbia University Medical Center

New York, United States
Suspended7 Study Centers