Not Yet RecruitingNot Applicable

Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial

22 participantsStarted 2024-08

Plain-language summary

This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases.

Who can participate

Age range6 Months – 16 Years

SexALL

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Inclusion criteria

✓. Males and females with body weight between 8 kg, and 30 kg
✓. Body surface area (BSA) between 0.4 m2 and 1.0 m2
✓. 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., , Kawasaki disease) 4. INTERMACS Profile 1 or 2 as evidenced by: a. Inability to wean from extra-corporeal membrane oxygenation (ECMO) or other temporary circulatory support (TCS), OR b.Inability to wean from mechanical ventilator support, OR c. Inotrope-dependent,decompensatedHFANDmeetoneormoreofthe following severity criteria within 48 hours prior to implant (unless otherwise noted), attributed to decompensated HF despite optimal medical therapy: i. Urine output \<0.5 cc/kg/hour for 12hr 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%) v. Acidosis: Base excess \>-5 vi. Inability to tolerate appropriate enteral calories vii. Inability to ambulate or participate in age-appropriate activities of daily living (ADLs) and/or cardiac rehabilitation/physical therapy

Exclusion criteria

✕. Single ventricle anatomy
✕. Presence of a mechanical heart valve
✕. Unrepairable severe aortic insufficiency 3. Stable inotrope dependence (INTERMACS profile 3) 4. Severe or irreversible renal dysfunction, liver dysfunction or pulmonary dysfunction. 5. Known contraindication to systemic anticoagulation (e.g., coagulopathy) 6. CPR with duration \>30 consecutive minutes within 48 hours prior to device implant or CPR with uncertain neurological status 7. ECMO use for \>10 consecutive days 8. Known cerebrovascular event within the past 30 days or uncertain neurological status 9. Unmanageable bleeding per judgment of the investigator 10. Ventricular dysfunction that is likely to recover (e.g., acute myocarditis, metabolic myopathy where LV dysfunction is present solely with intermittent acidosis/crises).

What they're measuring

Survival to heart transplant, recovery or 180 days of support in the absence of severe stroke.

Timeframe: 180 days

Freedom from symptomatic stroke

Timeframe: 12 months post-explant

Trial details

NCT IDNCT06348043

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Christopher SD Almond, MD, MPH

6507237913 calmond@stanford.edu

View on ClinicalTrials.gov More Heart Failure With Reduced Ejection Fraction trials