Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorStanford University
About this trial
This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females with body weight between 8 kg, and 30 kg
Body surface area (BSA) between 0.4 m2 and 1.0 m2
Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease (e.g., anomalous left coronary artery from the pulmonary artery [ALCAPA], aortic stenosis) or acquired heart disease (e.g., , Kawasaki disease) 4. INTERMACS Profile 1 or 2 as evidenced by: a. Inability to wean from extra-corporeal membrane oxygenation (ECMO) or other temporary circulatory support (TCS), OR b.Inability to wean from mechanical ventilator support, OR c. Inotrope-dependent,decompensatedHFANDmeetoneormoreofthe following severity criteria within 48 hours prior to implant (unless otherwise noted), attributed to decompensated HF despite optimal medical therapy: i. Urine output <0.5 cc/kg/hour for 12hr ii. Creatinine level >2 times the upper limit of normal (ULN) for age iii. Alanine aminotransferase (ALT) or total bilirubin level >3 times the ULN for age (either qualifies the patient) iv. Mixed venous oxygen saturation (SvO2) <55% (or arteriovenous oxygen difference >45%) v. Acidosis: Base excess >-5 vi. Inability to tolerate appropriate enteral calories vii. Inability to ambulate or participate in age-appropriate activities of daily living (ADLs) and/or cardiac rehabilitation/physical therapy
Disqualifiers
Single ventricle anatomy
Presence of a mechanical heart valve
Unrepairable severe aortic insufficiency 3. Stable inotrope dependence (INTERMACS profile 3) 4. Severe or irreversible renal dysfunction, liver dysfunction or pulmonary dysfunction. 5. Known contraindication to systemic anticoagulation (e.g., coagulopathy) 6. CPR with duration >30 consecutive minutes within 48 hours prior to device implant or CPR with uncertain neurological status 7. ECMO use for >10 consecutive days 8. Known cerebrovascular event within the past 30 days or uncertain neurological status 9. Unmanageable bleeding per judgment of the investigator 10. Ventricular dysfunction that is likely to recover (e.g., acute myocarditis, metabolic myopathy where LV dysfunction is present solely with intermittent acidosis/crises).
Trial design
Design model
Single group
Treatments tested in this trial
Jarvik 2015 LVAD
DeviceMedical device used to treat children awaiting heart transplant who fail optimal medical therapy.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: LVAD support with the Jarvik 2015Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Survival to heart transplant, recovery or 180 days of support in the absence of severe stroke.
Patient survival to heart transplant, recovery or 180 days of support in the absence of severe stroke as defined by the Pediatric Stroke Outcomes Measure (PSOM, (range 0 to 10 with 0 no deficit to 10 maximum deficit) performed at 12 months post-explant. Severe stroke is defined an abnormal PSOM score due to stroke that meets the following criteria: PSOM score of 3-4 in Part A (sensory and motor assessment) OR Score of 3-4 in Parts B and C combined (language comprehension and language production) OR Score of 2 in Part D (cognitive or behavioral deficit).
Time frame
180 days2
Freedom from symptomatic stroke
Freedom from symptomatic stroke based on the 12-month Pediatric Stroke Outcome Measure (PSOM, symptomatic stroke defined as a PSOM \>0 due to stroke, PSOM score range 0-10 with higher scores corresponding to more severe stroke injury). Participants meet criteria for no stroke if they do not meet ACTION criteria for stroke at 12 months or stroke is present with a PSOM score of 0).
Time frame
12 months post-explantSecondary outcomes
1
Incidence rate of all protocol-defined SAE's through 180 days of support definitely or probably related to the device
Incidence rate of all protocol-defined SAE's through 180 days of support definitely or probably related to the device using the ACTION definitions and rules for censoring and attribution, the industry standard in pediatric VAD therapy
Time frame
180 days2
Distribution of Pediatric Stroke Outcomes Measures
Distribution of Pediatric Stroke Outcomes Measures (PSOM scores) in children with a new stroke diagnosis during the trial as assessed at 12 months post-explant.
Time frame
12-months post explant for stroke occurring during the first 180 days of support3
The KOSCHI score
The Kings Outcomes Scale for Children Head Injury (KOSCHI) score (range 1-5, with 1-poor to 5-good functional state) for those diagnosed with a new stroke during the first 180 days as measured at 12 months post-explant.
Time frame
12 months post-explant in children with strokes occurring during the first 180 days of support4
Overall survival on Jarvik 2015 support to 180 days
Overall patient survival on Jarvik 2015 support without converting to a non-Jarvik device for left heart support (Kaplan-Meier estimate)
Time frame
180 daysLocations
Sponsors and contacts
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Stanford University
Lead sponsor
University of Texas
Collaborator
Carelon Research
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov
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