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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All Patients

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

Group Type OTHER

CentriMag Ventricular Assist System

Intervention Type DEVICE

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

Interventions

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CentriMag Ventricular Assist System

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No