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Pumps for Kids, Infants, and Neonates (PumpKIN)

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ClinicalTrials.gov Identifier: NCT02954497
Recruitment Status : Active, not recruiting
First Posted : November 3, 2016
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Jarvik Heart, Inc.
Information provided by (Responsible Party):
New England Research Institutes

Brief Summary:

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 : October 22, 2018
Estimated Primary Completion Date : April 2021
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. • 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 ]


Information from the National Library of Medicine

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

Inclusion Criteria

All children with severe (Ross or New York Heart Association (NYHA) class IV) heart failure despite optimal medical therapy (INTERMACS profiles for pediatrics: Profiles 1 or 2) who require mechanical circulatory support and meet the following criteria:

  1. Males and females within weight range: 8.0 Kg ≤ weight ≤ 30.0 Kg
  2. Males and females within Body surface area (BSA) range: 0.4 m2 ≤ BSA ≤ 1.0 m2
  3. Cardiac anatomy categories:

    1. 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)
    2. Challenging Cardiac Anatomy: Any challenging cardiac anatomy (including but not limited to single ventricle heart disease, RCM, HCM3-5) that, in the opinion of the investigator with confirmation from the PumpKIN Executive Committee, is difficult to support with available (e.g. pulsatile) devices.
  4. INTERMACS Profile 1 or 2 as evidenced by:

    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 upper limit of normal (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 different >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 vii. Inability to ambulate freely to participate fully in age-appropriate activities of daily living (ADLs) and/or cardiac rehabilitation/physical therapy, OR

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

Exclusion Criteria

To be eligible for this trial, the subjects must meet none of the following exclusion criteria at the time of enrollment or between the enrollment and device implant:

  1. Known contraindication to systemic anticoagulation
  2. Currently participating in an interventional trial whose protocol prevents effective application of the Jarvik 2015 device, 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 prior to stage II surgical palliation (i.e. prior to superior cavo-pulmonary anastomosis, also known as a Glenn or hemi-Fontan) or Fontan surgery
  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 antimicrobials 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

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


Locations
United States, California
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
CVolumbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Children's Medical Center - Dallas
Dallas, Texas, United States, 75235
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
New England Research Institutes
National Heart, Lung, and Blood Institute (NHLBI)
Jarvik Heart, Inc.
Investigators
Study Chair: William T Mahle, MD Children's Hospital of Atlanta, Emory University School of Medicine

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT02954497     History of Changes
Other Study ID Numbers: C01367
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: May 2018
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.

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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases