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

N/AWithdrawnNCT01171950

Abbott Medical Devices

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Heart Failure

Interventions

CentriMag Ventricular Assist SystemDEVICE

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Survival

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.

Time frame: 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant

Secondary Outcomes

Evaluation of end-organ function

Improvements in measures of end-organ function

Time frame: 30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant

Data from ClinicalTrials.gov

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