Pumps for Kids, Infants, and Neonates (PumpKIN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02954497|
Recruitment Status : Active, not recruiting
First Posted : November 3, 2016
Last Update Posted : January 23, 2018
PumpKIN is a randomized, multicenter, two-arm trial evaluating the investigational Jarvik 2015 VAD versus the EXCOR® Pediatric VAD in pediatric patients with heart failure. This study will enroll 88 subjects, 44 receiving the Jarvik 2015 and 44 receiving the EXCOR®, at up to 24 sites in the US and Canada.
The primary objectives of this investigational device exemption (IDE) clinical investigation are to (1) assess the safety of the investigational Jarvik 2015 through the evaluation of reported serious adverse events (SAEs) while on ventricular assist device (VAD) support up to the first 180 days post-implant and (2) explore the probable benefit of the investigational Jarvik 2015 by evaluating overall survival in the absence of severe neurologic impairment.
|Condition or disease||Intervention/treatment|
|Pediatric Heart Failure||Device: Surgical placement of the Jarvik 2015 VAD Device: Surgical placement of the EXCOR® Pediatric VAD|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pumps for Kids, Infants, and Neonates|
|Actual Study Start Date :||June 19, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||November 2022|
Experimental: Jarvik 2015 Device VAD
New, experimental continuous flow VAD
Device: Surgical placement of the Jarvik 2015 VAD
The Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device.
Active Comparator: EXCOR® Pediatric VAD
FDA approved pulsatile pediatric VAD
Device: Surgical placement of the EXCOR® Pediatric VAD
EXCOR® Pediatric VAD is an extracorporeal, pneumatically driven, pulsatile ventricular assist device.
- To assess the safety of the investigational Jarvik 2015 VAD through the evaluation of reported SAEs while on VAD support up to the first 180 days post-implant. [ Time Frame: First 180 Days post-implant ]Incidence rate of pediMACS defined adverse events per patient-day of randomized VAD support.
- To explore the probable benefit of the investigational Jarvik 2015 VAD by evaluating overall survival in the absence of severe neurologic impairment. [ Time Frame: First 180 Days post-implant ]Overall survival in the absence of severe neurologic impairment and in the absence of randomized device failure and meeting any of the following outcomes: (1) survival to induction of anesthesia for cardiac transplant surgery; (2) removal of randomized VAD and alive at 30 days post-explant; or (3) survival at 180 consecutive days of randomized VAD support.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954497
|United States, California|
|Lucile Packard Children's Hospital Stanford|
|Palo Alto, California, United States, 94304|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|St. Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Stollery Children's Hospital|
|Edmonton, Alberta, Canada, AB T6G 2B7|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, ON M5G 1X8|
|Study Chair:||William T Mahle, MD||Children's Hospital of Atlanta, Emory University School of Medicine|