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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01171950
• Other study ID #: PED-001
• Status: Withdrawn
• Phase: N/A
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CentriMag Ventricular Assist System
All patients will be treated with the CentriMag device for up to 30 days.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Thoratec Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of end-organ function	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