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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Thoratec Corporation

ClinicalTrials.gov Identifier:

NCT01171950

First received: July 27, 2010

Last updated: April 20, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 27, 2010

Last Updated Date

April 20, 2012

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survival [ Time Frame: 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01171950 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluation 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 ] [ Designated as safety issue: No ]

Improvements in measures of end-organ function

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Device: CentriMag Ventricular Assist System

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

Study Arm (s)

All Patients

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

Intervention: Device: CentriMag Ventricular Assist System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

5 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01171950

Other Study ID Numbers ^ICMJE

PED-001

Has Data Monitoring Committee

Yes

Responsible Party

Thoratec Corporation

Study Sponsor ^ICMJE

Thoratec Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Mark Macedo, BSN

Thoratec Corporation

Information Provided By

Thoratec Corporation

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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