Trials / Unknown
UnknownNCT02954497
Pumps for Kids, Infants, and Neonates
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Carelon Research · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Surgical placement of the Jarvik 2015 VAD | The Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device. |
| PROCEDURE | Surgical Placement of Jarvik 2015 VAD | Surgical Implant of the Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device. |
Timeline
- Start date
- 2018-10-22
- Primary completion
- 2023-06-09
- Completion
- 2023-09-15
- First posted
- 2016-11-03
- Last updated
- 2023-09-21
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02954497. Inclusion in this directory is not an endorsement.