CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients

CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01171950

Enrollment

Registered

2010-07-29

Start date

2009-06-30

Completion date

2012-12-31

Last updated

2022-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Thoratec Corporation

Brief summary

The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.

Interventions

DEVICECentriMag Ventricular Assist System

All patients will be treated with the CentriMag device for up to 30 days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 16 Years

Healthy volunteers

Inclusion criteria

1. Age 5 years to 16 years, inclusive 2. Inability to wean from cardiopulmonary bypass (CPB)

Exclusion criteria

1. Body weight \< 20 kg 2. Severe aortic insufficiency 3. Unrestricted intra-cardiac communications (i.e. large VSD) 4. Pulmonary vascular resistance index (PVRI) \> 10 IU 5. Presence of DIC 6. On hemodialysis (excluding hemofiltration) 7. Contraindications to systemic anticoagulation 8. Active systemic infection unresponsive to antibiotics 9. Unresolved malignancy 10. On other investigational VAS

Design outcomes

Primary

Measure	Time frame	Description
Survival	30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant	In patients who recover and do not go on to transplantation or a long-term device: • Survival 30 days after removal of the CentriMag VAS or to discharge, whichever is longer. In patients who do not recover: • Ability to be removed from the CentriMag VAS and survive to induction of anesthesia for implantation of a long-term device or heart transplantation.

Secondary

Measure	Time frame	Description
Evaluation of end-organ function	30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant	Improvements in measures of end-organ function

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026