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Ventricular Assist Device

Surgical Placement of Jarvik 2015 VAD for Heart Failure (PumpKIN Trial)

Phase < 1
Waitlist Available
Research Sponsored by HealthCore-NERI
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-explant
Awards & highlights

PumpKIN Trial Summary

This trial will enroll 10 subjects at up to 7 sites in the United States to assess the feasibility of using the Jarvik 2015 VAD in pediatric patients with severe heart failure who require mechanical circulatory support.

Eligible Conditions
  • Pediatric Heart Failure

PumpKIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-explant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-explant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Clinical Feasibility
Pivotal Trial continuation assessed by exploratory primary and secondary endpoints
+1 more
Secondary outcome measures
ALT level
Creatinine level
Extubation
+23 more

PumpKIN Trial Design

1Treatment groups
Experimental Treatment
Group I: Jarvik 2015 Device VADExperimental Treatment2 Interventions
New, experimental continuous flow VAD

Find a Location

Who is running the clinical trial?

HealthCore-NERILead Sponsor
72 Previous Clinical Trials
206,726 Total Patients Enrolled
3 Trials studying Heart Failure
3,468 Patients Enrolled for Heart Failure
Carelon ResearchLead Sponsor
71 Previous Clinical Trials
206,726 Total Patients Enrolled
3 Trials studying Heart Failure
3,468 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,815 Previous Clinical Trials
47,292,902 Total Patients Enrolled
203 Trials studying Heart Failure
677,217 Patients Enrolled for Heart Failure

Media Library

Jarvik 2015 VAD (Ventricular Assist Device) Clinical Trial Eligibility Overview. Trial Name: NCT02954497 — Phase < 1
Heart Failure Research Study Groups: Jarvik 2015 Device VAD
Heart Failure Clinical Trial 2023: Jarvik 2015 VAD Highlights & Side Effects. Trial Name: NCT02954497 — Phase < 1
Jarvik 2015 VAD (Ventricular Assist Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02954497 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues is this clinical experiment being conducted in?

"There are 7 enrolment sites for this trial, located in cities like Boston, Dallas and Palo Alto. It is recommended that patients select the closest location to minimize travel requirements when enrolling."

Answered by AI

Is this trial presently seeking participants?

"The trial's page on clinicaltrials.gov states that it is not actively looking for patients at this time, although the initial posting was back in October 2018 and its last update was November 2022. However there are 701 other trials currently enrolling subjects."

Answered by AI

What are the ambitions of this clinical endeavor?

"Per the clinical trial sponsor, Jarvik Heart, Inc., their primary aim will be assessed over a 30-day post-transplant/recovery period. Additional objectives include Pediatric Stroke Outcome Measure Neurological Exam (PSOM-NE) score which is graded on a 0 - 10 scale with higher being worse outcome and measured at 180 days or prior to explant; overall survival without severe neurological impairment within 180 consecutive days of VAD support and new neurological dysfunction up to day 180 post implantation."

Answered by AI
~1 spots leftby Mar 2025