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

June 23, 2022 updated by: Abbott Medical Devices

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: All Patients
All patients meeting the patient selection criteria will be treated with the CentriMag device.
Device: CentriMag Ventricular Assist System
All patients will be treated with the CentriMag device for up to 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 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.
30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Thoratec Corporation

Investigators

  • Study Director: Pooja Chatterjee, Thoratec Corporation/Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 27, 2010

First Posted (ESTIMATE)

July 29, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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