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Pumps for Kids, Infants, and Neonates (PumpKIN)

This study is currently recruiting participants.
Verified June 2017 by New England Research Institutes
Sponsor:
ClinicalTrials.gov Identifier:
NCT02954497
First Posted: November 3, 2016
Last Update Posted: June 21, 2017
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.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Jarvik Heart, Inc.
Information provided by (Responsible Party):
New England Research Institutes
  Purpose

PumpKIN is a randomized, multicenter, two-arm trial evaluating the investigational Jarvik 2015 VAD versus the EXCOR® Pediatric VAD in pediatric patients with heart failure. This study will enroll 88 subjects, 44 receiving the Jarvik 2015 and 44 receiving the EXCOR®, at up to 24 sites in the US and Canada.

The primary objectives of this investigational device exemption (IDE) clinical investigation are to (1) assess the safety of the investigational Jarvik 2015 through the evaluation of reported serious adverse events (SAEs) while on ventricular assist device (VAD) support up to the first 180 days post-implant and (2) explore the probable benefit of the investigational Jarvik 2015 by evaluating overall survival in the absence of severe neurologic impairment.


Condition Intervention
Pediatric Heart Failure Device: Surgical placement of the Jarvik 2015 VAD Device: Surgical placement of the EXCOR® Pediatric VAD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pumps for Kids, Infants, and Neonates

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • To assess the safety of the investigational Jarvik 2015 VAD through the evaluation of reported SAEs while on VAD support up to the first 180 days post-implant. [ Time Frame: First 180 Days post-implant ]
    Incidence rate of pediMACS defined adverse events per patient-day of randomized VAD support.

  • To explore the probable benefit of the investigational Jarvik 2015 VAD by evaluating overall survival in the absence of severe neurologic impairment. [ Time Frame: First 180 Days post-implant ]
    Overall survival in the absence of severe neurologic impairment and in the absence of randomized device failure and meeting any of the following outcomes: (1) survival to induction of anesthesia for cardiac transplant surgery; (2) removal of randomized VAD and alive at 30 days post-explant; or (3) survival at 180 consecutive days of randomized VAD support.


Estimated Enrollment: 88
Actual Study Start Date: June 19, 2017
Estimated Study Completion Date: November 2022
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: EXCOR® Pediatric VAD
FDA approved pulsatile pediatric VAD
Device: Surgical placement of the EXCOR® Pediatric VAD
EXCOR® Pediatric VAD is an extracorporeal, pneumatically driven, pulsatile ventricular assist device.

  Eligibility

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.


Ages Eligible for Study:   Child, Adult, Senior
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 ≤ 20.0 Kg
  2. Males and females within Body surface area (BSA) range: 0.4 m2 ≤ BSA ≤ 0.8 m2
  3. Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease (e.g. ALCAPA, aortic stenosis) or acquired heart disease (e.g., myocarditis, Kawasaki disease)
  4. Documented evidence of

    • Inability to wean from ECMO or other temporary mechanical support OR
    • Inotrope-dependent, decompensated heart failure with inability to wean from ventilator support OR
    • Inotrope-dependent, decompensated heart failure AND a combination of two of the following criteria within 48 hours prior to implant (unless otherwise noted) which is attributed to decompensated heart failure despite optimal medical therapy:

      • Urine output < 0.5 cc/Kg/hr
      • Creatinine level > 2 times the ULN for age
      • ALT or total bilirubin result >3 times the ULN for age (either qualifies the patient)
      • Mixed venous oxygen saturation (SvO2) < 55%
      • Inability to tolerate enteral feeds (>75% of maintenance calories) for ≥7 days
      • Acidosis: Base excess <-5
  5. Potentially 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 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 for systemic anticoagulation
  2. Currently participating in an interventional trial whose protocol prevents effective application of one or both treatment arms, potentially has an independent effect on trial endpoints, or otherwise interferes with execution of the PumpKIN protocol
  3. Any complex cardiac diagnosis (including but not limited to single ventricle anatomy, restrictive cardiomyopathy) that, in the opinion of the investigator, could independently affect the likelihood of the subject meeting the primary endpoint
  4. Presence of a mechanical heart valve
  5. Unresolved malignancy
  6. CPR with duration >30 consecutive minutes within 48 hours prior to device implant or CPR with uncertain neurological status prior to device implant
  7. The following are exclusionary if found 24 hours or less prior to device implant:

    • Renal dysfunction that is severe or, in the opinion of the investigator, irreversible
    • Hepatic dysfunction that is severe or, in the opinion of the investigator, irreversible
    • Severe or irreversible pulmonary dysfunction
    • ECMO use for > 10 consecutive days
    • Severe aortic insufficiency
    • Active, systemic infection unresponsive to antimicrobials
    • Known cerebrovascular event within the past 30 days or uncertain neurological status
    • Severe RV dysfunction or significant arrhythmia requiring treatment with an RV assist device (RVAD) (i.e., biventricular assist device)
    • Unmanageable bleeding per judgment of the investigator
  Contacts and Locations
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
Contact: Sandra Siami, MPH 6179723317 ssiami@neriscience.com

Locations
United States, California
Lucile Packard Children's Hospital Stanford Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Olaf Reinhartz, MD       orx@stanford.edu   
United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Francis Flynn-Thompson, MD       Francis.Fynn-Thompson@cardio.chboston.org   
United States, Missouri
St. Louis Children's Hospital Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Pirooz Eghtesady, MD       eghtesadyp@wudosis.wustl.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: David Morales, MD       david.morales@cchmc.org   
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Iki Adachi, MD       ixadachi@texaschildrens.org   
Canada, Alberta
Stollery Children's Hospital Not yet recruiting
Edmonton, Alberta, Canada, AB T6G 2B7
Contact: Ivan Rebeyka, MD       Ivan.Rebeyka@albertahealthservices.ca   
Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, ON M5G 1X8
Contact: Osami Honjo, MD       osami.honjo@sickkids.ca   
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
  More Information

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT02954497     History of Changes
Other Study ID Numbers: C01367
First Submitted: October 31, 2016
First Posted: November 3, 2016
Last Update Posted: June 21, 2017
Last Verified: June 2017
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