Pumps for Kids, Infants, and Neonates
- Conditions
- Pediatric Heart Failure
- Interventions
- Device: Surgical placement of the Jarvik 2015 VADProcedure: Surgical Placement of Jarvik 2015 VAD
- Registration Number
- NCT02954497
- Lead Sponsor
- Carelon Research
- Brief Summary
PumpKIN is a multicenter, prospective, single-arm feasibility study; Evaluating the investigational Jarvik 2015 VAD in pediatric patients with heart failure. This feasibility trial will enroll 10 subjects 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Jarvik 2015 Device VAD Surgical Placement of Jarvik 2015 VAD New, experimental continuous flow VAD Jarvik 2015 Device VAD Surgical placement of the Jarvik 2015 VAD New, experimental continuous flow VAD
- Primary Outcome Measures
Name Time Method Adverse Events 30 days or transplant/recovery (whichever comes first) To evaluate the protocol defined (INTERMACS version 5.0) serious adverse events on Jarvik 2015 support up to transplant, recovery or 30 days of support
Clinical Feasibility 30 days or transplant/recovery (whichever comes first) To assess the clinical feasibility of the investigational Jarvik 2015 VAD by evaluating survival in the absence of severe neurological impairment or death, or device failure up to the clinical endpoint defined as transplant, recovery or 30 days of support
Pivotal Trial continuation assessed by exploratory primary and secondary endpoints 12-months post-explant To evaluate patients with respect to exploratory primary and secondary endpoints to inform the choice of appropriate primary and secondary endpoints for the pivotal trial.
Technical, surgical, and clinical milestones assessed by feasibility milestones up to 180 days or transplant/recovery To describe the technical, surgical and clinical feasibility by achieving specific technical, surgical, and clinical milestones that typically accompany a successful VAD support run
- Secondary Outcome Measures
Name Time Method Extubation 30 days post-implant Time to extubation
Inotropic agents 12 months post-explant Time to discontinuation of inotropic agents
Incidence of Adverse Events related to device 180 days post-implant Incidence rate of protocol-defined AEs possibly, probably, or definitely related to the device per day of mechanical circulatory support, up to the first 180 days post-implant.
Neurological dysfunction 180 days post-implant The incidence of new neurological dysfunction up to 180 days post-implant.
Incidence of Adverse Events per patient days of VAD support 180 days post-implant The incidence rate of protocol-defined AEs (INTERMACS, version 5) per patient-day of VAD support up to the first 180 days post-implant.
King's Outcome Scale for Childhood Head Injury score (0 -5 scale, higher = worse outcome) 180 days and 12 months post-explant King's Outcome Scale for Childhood Head Injury (KOSCHI) score measured at 180 days post-implant or immediately prior to explant, and at 12 months post-explant.
TPN discontinuation 12 months post-explant Time to discontinuation of total parenteral nutrition (TPN)
MRI 12 months post-explant Brain Magnetic Resonance Imaging (MRI) performed 12 months post-explant to assess for clinically silent neurologic injuries.
Overall survival in the absence of device failure 180 days or tranplant/recovery (whichever comes first) Overall survival in the absence of device failure but without regard for neurologic status, meeting any of the following outcomes: Survival to induction of anesthesia for cardiac transplant surgery, Survival to recovery (removal of Jarvik 2015 VAD and alive at 30 days post-explant), Survival at 180 consecutive days of Jarvik 2015 VAD support
Survival at 12 months post-explant 12 months post-explant Survival at 12 months post-explant
Incidence rate of pump exchange device explant Incidence rate of pump exchanges
Pediatric Stroke Outcome Measure Neurological Exam (PSOM-NE) score (0 - 10 scale, higher = worse outcome) 180 days and 12 months post-explant Pediatric Stroke Outcome Measure-Neurological (PSOM-NE) score measured at 180 days post-implant or immediately prior to explant, and at 12 months post-explant.
Vineland Adaptive Behavior Scales score (scoring and scale different by domain) 12 months post-explant Vineland Adaptive Behavior Scales (VABS II) measured at 12 months post-explant.
Ventricular Assist Device Quality of Life score (scoring and scale different per question) 30 days, 90 days, 12 months post-explant VAD QL measured at 30 and 90 days post-implant, and every 90 days thereafter, while on Jarvik 2015 VAD support.
Sedation 30 days post-implant Time to discontinuation of sedation such that subject is alert and interactive (e.g., engaging in age-appropriate play).
ALT level 180 days or immediately prior to explant Proportion of subjects with an alanine aminotransferase (ALT) level below the ULNULN
Survival in absence of severe neurological impairment 180 days or tranplant/recovery (whichever comes first) Overall survival in the absence of a severe neurologic impairment and in the absence of device failure at 180 days following VAD implant and meeting any of the following outcomes: Survival to induction of anesthesia for cardiac transplant surgery, Recovery (removal of VAD and alive at 30 days post-explant), Survival at 180 consecutive days of VAD support
Survival at 30 days post-implant 30 days post-implant Survival at 30 days post-implant
Survival at 180 days post-implant 180 days post-implant Survival at 180 days post-implant
Time to pump failure device explant Time to first pump failure
Pediatric Stroke Recurrence and Recovery Questionnaire score (0 -10 scale, higher = worse outcome) 180 days and 12 months post-explant Pediatric Stroke Recurrence and Recovery Questionnaire (RRQ) measured at 180 days post-implant or immediately prior to explant, and at 12 months post-explant.
Pediatric Quality of Life score (0-4 scale per domain, higher = worse outcome) 12 months post-explant PedsQL20 measured at 180 days post-implant or immediately prior to explant and 12 months post-explant.
Incidence rate of pump failure device explant Incidence rate of pump failures
Paralytics discontinuation 12 months post-explant Time to discontinuation of paralytics
Time to first pump exchange device explant Time to first pump exchanges
Creatinine level 180 days or immediately prior to explant Proportion of subjects with a creatinine level below the ULNULN
Trial Locations
- Locations (7)
Lucile Packard Children's Hospital Stanford
🇺🇸Palo Alto, California, United States
Children's Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States