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Surgical Placement of Jarvik 2015 VAD for Heart Failure (PumpKIN Trial)
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.
- Pediatric Heart Failure
PumpKIN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PumpKIN Trial Design
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Who is running the clinical trial?
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- Group 1: Jarvik 2015 Device VAD
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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