Pumps for Kids, Infants, and Neonates — PumpKIN

Pediatric Heart Failure Clinical Trial

Official title:
Pumps for Kids, Infants, and Neonates

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02954497
Study type	Interventional
Source	Carelon Research
Contact
Status	Active, not recruiting
Phase	Early Phase 1
Start date	October 22, 2018
Completion date	September 15, 2023

View Details

See also
	Status	Clinical Trial	Phase
	Enrolling by invitation	`NCT05017077` - Home Monitoring in Pediatric Heart Failure	N/A
	Completed	`NCT02678312` - Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure	Phase 2/Phase 3