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Trial record 1 of 739 for:    pumps for kids
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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. Identifier: NCT02954497
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : July 9, 2020
National Heart, Lung, and Blood Institute (NHLBI)
Jarvik Heart, Inc.
Information provided by (Responsible Party):

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

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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. • 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 [ Time Frame: 30 days ]

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.

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

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) that, in the opinion of the investigator with confirmation from one of the DCCC Clinical PIs, 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 prior to implant 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%) 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. 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.

Exclusion Criteria

To be eligible for this trial, the subjects must meet none of the following exclusion criteria within 48 hours prior to 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
  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
  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
  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
  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 identifier (NCT number): NCT02954497

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Contact: Sandra Siami, MPH 6179723317

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United States, California
Lucile Packard Children's Hospital Stanford Recruiting
Palo Alto, California, United States, 94304
Contact: David Rosenthal, MD   
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kirk Kanter, MD    404-785-6330   
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Francis Flynn-Thompson, MD   
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Paul Chai, MD    212-305-5975   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: David Morales, MD   
United States, Texas
Children's Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Ryan Davies, MD    214-456-5000   
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Iki Adachi, MD   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Jarvik Heart, Inc.
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Study Chair: William T Mahle, MD Children's Hospital of Atlanta, Emory University School of Medicine
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Responsible Party: HealthCore-NERI Identifier: NCT02954497    
Other Study ID Numbers: C01367
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: November 2019
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.

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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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases