Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348043
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-29
Brief Title:
Pumps for Kids Infants and Neonates PumpKIN The Jarvik 2015 Pivotal Trial
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Circulatory Support in Pediatric Heart Failure Patients Using the Jarvik 2015 LVAD A Pivotal
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PumpKIN
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UG3HL163311-01A1 | NIH | None | httpsreporternihgovquickSearch1UG3HL163311-01A1 |