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Pumps for Kids, Infants, and Neonates

NCT02954497 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-09-21

No results posted yet for this study

Summary

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.

Conditions

  • Pediatric Heart Failure

Interventions

DEVICE

Surgical placement of the Jarvik 2015 VAD

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

PROCEDURE

Surgical Placement of Jarvik 2015 VAD

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Jarvik Heart, Inc.

    collaborator INDUSTRY

  • Carelon Research

    lead OTHER

Principal Investigators

  • William T Mahle, MD · Children's Hospital of Atlanta, Emory University School of Medicine

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2023-06-09
Completion
2023-09-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02954497 on ClinicalTrials.gov