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 : June 20, 2018
PumpKIN is a multicenter, two prospective, single-arm feasibility studies; One with Standard Cardiac Anatomy and one with Challenging Cardiac Anatomy evaluating the investigational Jarvik 2015 VAD in pediatric patients with heart failure. This feasibility trial will enroll 10 subjects, 5 Standard Cardiac Anatomy subjects reaching endpoints, and 5 Challenging Cardiac Anatomy subjects reaching endpoints 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.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Heart Failure||Device: Surgical placement of the Jarvik 2015 VAD Procedure: Surgical Placement of Jarvik 2015 VAD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pumps for Kids, Infants, and Neonates|
|Actual Study Start Date :||May 20, 2018|
|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.
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.
- • To assess the clinical feasibility of the investigational Jarvik 2015 VAD by evaluating survival in the absence of device-related severe neurological impairment or death, or non-operational (Non-OP) device failure up to the clinical endpoint [ Time Frame: 30 days ]
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, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Study Chair:||William T Mahle, MD||Children's Hospital of Atlanta, Emory University School of Medicine|