NCT01171950

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2009

Typical duration for not_applicable heart-failure

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

3.5 years

First QC Date

July 27, 2010

Last Update Submit

June 23, 2022

Conditions

Heart Failure

Keywords

Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • Evaluation of end-organ function

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

Study Arms (1)

All Patients

OTHER

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

Device: CentriMag Ventricular Assist System

Interventions

CentriMag Ventricular Assist SystemDEVICE

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

All Patients

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Pooja Chatterjee

    Thoratec Corporation/Abbott

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2010

First Posted

July 29, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 24, 2022

Record last verified: 2022-06