NCT06348043

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

Circulatory Support in Pediatric Heart Failure Patients Using the Jarvik 2015 LVAD: A Pivotal

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 6 Months – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a NHLBI-funded study is a 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 where few LVAD options are available and require hospital confinement. Children weighing 8 to 30 kg will be eligible if they have end-stage heart failure refractory to medical therapy due to severe systolic dysfunction. Children with single ventricle heart disease, heart failure with preserved ejection fraction (HFpEF), those requiring BIVAD support, and those with irreversible end-organ dysfunction will be excluded. The primary probable benefit endpoint of the study is survival to heart transplant, recovery or 180 days of support in the absence of severe stroke. The primary safety endpoint of the study is freedom from any new symptomatic stroke. A total of 22 subjects will be enrolled in the trial at 14 sites in the US and Europe. Subjects will be enrolled over roughly 3 years (38 months) and followed for 1 year post explant. 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. Children

Conditions

• Heart Failure With Reduced Ejection Fraction
• Pediatric HD, Stage IV
• LVAD

Interventions

Type	Name	Description
DEVICE	Jarvik 2015 LVAD	Medical device used to treat children awaiting heart transplant who fail optimal medical therapy.

Timeline

• Start date: 2024-08-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2024-04-04
• Last updated: 2024-04-04

Regulatory

• FDA-regulated device study