Clinical Trials Logo
  1. Home
  2. Other
  3. NCT06348043

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

Heart Failure With Reduced Ejection Fraction Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06348043
Study type Interventional
Source Stanford University
Contact Christopher SD Almond, MD, MPH
Phone 6507237913
Email calmond@stanford.edu
Status Not yet recruiting
Phase N/A
Start date August 2024
Completion date December 2029
View Details
See also
  Status Clinical Trial Phase
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Completed NCT03614169 - Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB N/A
Recruiting NCT05278962 - HF Patients With LVADs Being Treated With SGLT2i Phase 4
Completed NCT04210375 - Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) Phase 1
Not yet recruiting NCT06433687 - Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
Completed NCT05001165 - Dashboard Activated Services and Tele-Health for Heart Failure N/A
Active, not recruiting NCT03701880 - Early Use of Ivabradine in Heart Failure N/A
Recruiting NCT05650658 - Left vs Left Randomized Clinical Trial N/A
Not yet recruiting NCT06299436 - Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
Recruiting NCT05992116 - Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
Recruiting NCT05365568 - Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study N/A
Active, not recruiting NCT05204238 - Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Not yet recruiting NCT04420065 - Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure N/A
Terminated NCT03479424 - Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
Completed NCT02113033 - VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients Phase 2
Recruiting NCT03209180 - Immediate Release Versus Slow Release Carvedilol in Heart Failure Phase 4
Recruiting NCT05299879 - Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
Recruiting NCT05637853 - Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
Completed NCT03870074 - CPET Predicts Long-term Survival and Positive Response to CRT
Recruiting NCT04590001 - Effect of the MobiusHD® in Patients With Heart Failure N/A