Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02954497
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : January 11, 2021
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Jarvik Heart, Inc.
Information provided by (Responsible Party):
HealthCore-NERI

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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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 : October 22, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Clinical Feasibility [ Time Frame: 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

  2. Adverse Events [ Time Frame: 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

  3. Technical, surgical, and clinical milestones assessed by feasibility milestones [ Time Frame: 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

  4. Pivotal Trial continuation assessed by exploratory primary and secondary endpoints [ Time Frame: 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.


Secondary Outcome Measures :
  1. Incidence of Adverse Events per patient days of VAD support [ Time Frame: 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.

  2. Incidence of Adverse Events related to device [ Time Frame: 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.

  3. Neurological dysfunction [ Time Frame: 180 days post-implant ]
    The incidence of new neurological dysfunction up to 180 days post-implant.

  4. Pediatric Stroke Outcome Measure Neurological Exam (PSOM-NE) score (0 - 10 scale, higher = worse outcome) [ Time Frame: 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.

  5. King's Outcome Scale for Childhood Head Injury score (0 -5 scale, higher = worse outcome) [ Time Frame: 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.

  6. Pediatric Stroke Recurrence and Recovery Questionnaire score (0 -10 scale, higher = worse outcome) [ Time Frame: 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.

  7. Vineland Adaptive Behavior Scales score (scoring and scale different by domain) [ Time Frame: 12 months post-explant ]
    Vineland Adaptive Behavior Scales (VABS II) measured at 12 months post-explant.

  8. Pediatric Quality of Life score (0-4 scale per domain, higher = worse outcome) [ Time Frame: 12 months post-explant ]
    PedsQL20 measured at 180 days post-implant or immediately prior to explant and 12 months post-explant.

  9. Ventricular Assist Device Quality of Life score (scoring and scale different per question) [ Time Frame: 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.

  10. Paralytics discontinuation [ Time Frame: 12 months post-explant ]
    Time to discontinuation of paralytics

  11. TPN discontinuation [ Time Frame: 12 months post-explant ]
    Time to discontinuation of total parenteral nutrition (TPN)

  12. Extubation [ Time Frame: 30 days post-implant ]
    Time to extubation

  13. Inotropic agents [ Time Frame: 12 months post-explant ]
    Time to discontinuation of inotropic agents

  14. Sedation [ Time Frame: 30 days post-implant ]
    Time to discontinuation of sedation such that subject is alert and interactive (e.g., engaging in age-appropriate play).

  15. MRI [ Time Frame: 12 months post-explant ]
    Brain Magnetic Resonance Imaging (MRI) performed 12 months post-explant to assess for clinically silent neurologic injuries.

  16. Survival in absence of severe neurological impairment [ Time Frame: 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

  17. Overall survival in the absence of device failure [ Time Frame: 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

  18. Survival at 30 days post-implant [ Time Frame: 30 days post-implant ]
    Survival at 30 days post-implant

  19. Survival at 180 days post-implant [ Time Frame: 180 days post-implant ]
    Survival at 180 days post-implant

  20. Survival at 12 months post-explant [ Time Frame: 12 months post-explant ]
    Survival at 12 months post-explant

  21. Time to pump failure [ Time Frame: device explant ]
    Time to first pump failure

  22. Incidence rate of pump failure [ Time Frame: device explant ]
    Incidence rate of pump failures

  23. Time to first pump exchange [ Time Frame: device explant ]
    Time to first pump exchanges

  24. Incidence rate of pump exchange [ Time Frame: device explant ]
    Incidence rate of pump exchanges

  25. Creatinine level [ Time Frame: 180 days or immediately prior to explant ]
    Proportion of subjects with a creatinine level below the ULNULN

  26. ALT level [ Time Frame: 180 days or immediately prior to explant ]
    Proportion of subjects with an alanine aminotransferase (ALT) level below the ULNULN



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Children must meet all of the following criteria:

  1. Males and females within weight range 8 to 30 kg
  2. Body surface area (BSA) 0.4 m2 to 1.0 m2
  3. Cardiac Diagnosis:

    a. Standard Cardiac Anatomy : 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., myocarditis, Kawasaki disease)

  4. INTERMACS Profile 1 or 2 as evidenced by one or more of the following:

    1. Inability to wean from extra-corporeal membrane oxygenation (ECMO) or other temporary circulatory support (TCS), OR
    2. Inability to wean from mechanical ventilator support, OR
    3. Inotrope-dependent, decompensated heart failure AND meet one or more of the following criteria within 48 hours prior to implant (unless otherwise noted) which is attributed to decompensated heart failure despite optimal medical therapy:

    i. Urine output <0.5 cc/kg/hour for 12hr within 48 hours ii. Creatinine level >2 times the ULN for age iii. Alanine aminotransferase (ALT) or total bilirubin result >3 times the ULN for age (either qualifies the patient) iv. Mixed venous oxygen saturation (SvO2) <55% (or arteriovenous oxygen difference of >45%) in two repeated measurements v. Acidosis: Base excess >-5 in 2 or more measurements vi. Inability to tolerate appropriate enteral calories as prescribed by a registered dietician d. Inability to ambulate freely to participate fully in age-appropriate activities of daily living (ADLs) and/or cardiac rehabilitation/physical therapy

  5. LVAD support is intended for bridge-to transplant. Subject is listed for transplant or eligible (i.e., no medical or surgical contraindications) to be listed for cardiac transplant, United Network for Organ Sharing (UNOS) status 1A, or equivalent
  6. Written consent of parent(s) or legally authorized representative (LAR) where appropriate.

Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:

  1. Known contraindication for systemic anticoagulation
  2. Currently participating in an interventional trial whose protocol prevents effective application of Jarvik 2015, potentially has an independent effect on trial endpoints, or otherwise interferes with execution of the PumpKIN protocol
  3. Stable inotrope dependence (INTERMACS profile 3)
  4. Single ventricle anatomy
  5. Presence of a mechanical heart valve
  6. Unresolved malignancy
  7. CPR with duration >30 consecutive minutes within 48 hours prior to device implant or CPR with uncertain neurological status prior to device implant
  8. Renal dysfunction that is severe or, in the opinion of the investigator, irreversible
  9. Hepatic dysfunction that is severe or, in the opinion of the investigator, irreversible
  10. Severe or irreversible pulmonary dysfunction
  11. ECMO use for >10 consecutive days
  12. Unrepairable severe aortic insufficiency
  13. Active, systemic infection unresponsive to antimicrobial therapy
  14. Known cerebrovascular event within the past 30 days or uncertain neurological status
  15. Severe right ventricular (RV) dysfunction or significant arrhythmia requiring treatment with an RV assist device (RVAD) (i.e., biventricular assist device)
  16. Unmanageable bleeding per judgment of the investigator
  17. Ventricular dysfunction that is likely to recover (e.g. myocarditis, metabolic myopathy where LV dysfunction is present solely with intermittent acidosis/crises).
  18. Left ventricular end-diastolic dimension or left ventricular end-diastolic volume z score of < +2.5 end-diastolic dimension or ventricular end-diastolic volume z score of < +3.0
  19. Left ventricular ejection fraction of >35%

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ashley Magnavita, MPH 6179723182 ext 6179723182 amagnavita@healthcore.com

Locations
Layout table for location information
United States, California
Lucile Packard Children's Hospital Stanford Recruiting
Palo Alto, California, United States, 94304
Contact: David Rosenthal, MD       davidnr@stanford.edu   
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kirk Kanter, MD    404-785-6330    kkanter@emory.edu   
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Francis Flynn-Thompson, MD       Francis.Fynn-Thompson@cardio.chboston.org   
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Paul Chai, MD    212-305-5975    pjc@cumc.columbia.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: David Morales, MD       david.morales@cchmc.org   
United States, Texas
Children's Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Ryan Davies, MD    214-456-5000    ryan.davies@utshouthwestern.edu   
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Iki Adachi, MD       ixadachi@texaschildrens.org   
Sponsors and Collaborators
HealthCore-NERI
National Heart, Lung, and Blood Institute (NHLBI)
Jarvik Heart, Inc.
Investigators
Layout table for investigator information
Study Chair: William T Mahle, MD Children's Hospital of Atlanta, Emory University School of Medicine
Layout table for additonal information
Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT02954497    
Other Study ID Numbers: C01367
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Limited use data set will be made available through NHLBI after the conclusion of the trial.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by HealthCore-NERI:
ventricular assist device
congenital heart disease
heart failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases