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

Abbott

Status: Withdrawn

Conditions: Heart Failure

Treatments: Device: CentriMag Ventricular Assist System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01171950

PED-001

Details and patient eligibility

About

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.

Sex: All

Ages: 5 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

All Patients

Other group

Description:

All patients meeting the patient selection criteria will be treated with the CentriMag device.

Treatment:

Device: CentriMag Ventricular Assist System