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Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial

NCT06348043 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-04-04

No results posted yet for this study

Summary

This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases.

Conditions

  • Heart Failure With Reduced Ejection Fraction
  • Pediatric HD, Stage IV
  • LVAD

Interventions

DEVICE

Jarvik 2015 LVAD

Medical device used to treat children awaiting heart transplant who fail optimal medical therapy.

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • Carelon Research

    collaborator OTHER

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

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • William T Mahle, MD · Children's Healthcare of Atlanta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Device
Yes

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Companies

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 NCT06348043 on ClinicalTrials.gov