Pumps for Kids, Infants, and Neonates

NCT02954497 | Unknown Early Phase 1 DMC FDA Device

• 1 other identifier: C01367
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 7

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.

Conditions

Pediatric Heart Failure

Keywords

ventricular assist device; congenital heart disease; heart failure

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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.

  12-months post-explant

Secondary Outcomes (26)

• Incidence of Adverse Events per patient days of VAD support

  180 days post-implant

• Incidence of Adverse Events related to device

  180 days post-implant

• Neurological dysfunction

  180 days post-implant

• Pediatric Stroke Outcome Measure Neurological Exam (PSOM-NE) score (0 - 10 scale, higher = worse outcome)

  180 days and 12 months post-explant

• King's Outcome Scale for Childhood Head Injury score (0 -5 scale, higher = worse outcome)

  180 days and 12 months post-explant

Study Arms (1)

Jarvik 2015 Device VAD

EXPERIMENTAL

New, experimental continuous flow VAD

Device: Surgical placement of the Jarvik 2015 VAD; Procedure: Surgical Placement of Jarvik 2015 VAD

Interventions

Surgical placement of the Jarvik 2015 VAD DEVICE

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

Jarvik 2015 Device VAD

Surgical Placement of Jarvik 2015 VAD PROCEDURE

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

Jarvik 2015 Device VAD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Known contraindication for systemic anticoagulation
• 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
• Stable inotrope dependence (INTERMACS profile 3)
• Single ventricle anatomy
• Presence of a mechanical heart valve
• Unresolved malignancy
• CPR with duration \>30 consecutive minutes within 48 hours prior to device implant or CPR with uncertain neurological status 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
• Unrepairable severe aortic insufficiency
• Active, systemic infection unresponsive to antimicrobial therapy
• Known cerebrovascular event within the past 30 days or uncertain neurological status
• Severe right ventricular (RV) dysfunction or significant arrhythmia requiring treatment with an RV assist device (RVAD) (i.e., biventricular assist device)

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Jarvik Heart, Inc.: collaborator

Study Sites (7)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Medical Center - Dallas

Dallas, Texas, 75235, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Failure

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• William T Mahle, MD

  Children's Hospital of Atlanta, Emory University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Jarvik 2015

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 3, 2016
• Study Start: October 22, 2018
• Primary Completion: June 9, 2023
• Study Completion: September 15, 2023
• Last Updated: September 21, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (7)