Pumps for Kids, Infants, and Neonates

Early Phase 1UnknownNCT02954497

Carelon Research7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Pediatric Heart Failure

Interventions

Surgical placement of the Jarvik 2015 VADDEVICE

The Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device.

Surgical Placement of Jarvik 2015 VADPROCEDURE

Surgical Implant of the Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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%

Locations (7)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Clinical Feasibility

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

Time frame: 30 days or transplant/recovery (whichever comes first)

Adverse Events

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

Time frame: 30 days or transplant/recovery (whichever comes first)

Technical, surgical, and clinical milestones assessed by feasibility milestones

To describe the technical, surgical and clinical feasibility by achieving specific technical, surgical, and clinical milestones that typically accompany a successful VAD support run

Time frame: up to 180 days or transplant/recovery

Pivotal Trial continuation assessed by exploratory primary and secondary endpoints

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.

Time frame: 12-months post-explant

Secondary Outcomes

Incidence of Adverse Events per patient days of VAD support

The incidence rate of protocol-defined AEs (INTERMACS, version 5) per patient-day of VAD support up to the first 180 days post-implant.

Time frame: 180 days post-implant

Incidence of Adverse Events related to device

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.

Data from ClinicalTrials.gov

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