CentriMag RVAS Post-Approval

Overview

Status: Recruiting
Keywords: Heart Failure , RVAD , Ventricular Assist Device , Right Heart Failure
IRB Number: 00057861
Specialty: Cardiothoracic Surgery
Sub Specialties: Heart Failure

Brief Summary

The study objective is to gather post market clinical data in 25 patients on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause. Objectives studied include:

a) Duration of right ventricular support

b) Incidence of adverse effects

c) Evaluation of end-organ function

d) Evaluation of hemodynamics

e) Survival at 30 days post RVAD removal

The study hypothesis is: Survival to 30 days or hospital discharge (whichever is longer) will exceed 10% for patients who do not undergo implantation of a long-term device, OR survival to induction of anesthesia for patients who receive a transplant or long-term device.

Primary endpoint is:

In patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer).

In patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant.

Detailed Description

On October 11, 2008, Thoratec (formerly Levitronix) received HDE approval for use of the CentriMag RVAS in patients with acute right ventricular failure and is intended for use in patients to provide temporary circulatory support for up to 14 days and in patients with BSA > 1.4 m2.

Principal Investigator: Craig Selzman
Department: Cardiothoracic Divison
Co Investigator:

Contact Information

Name:Erin Davis
Phone: 801-581-5834
Email: erin.davis@hsc.utah.edu

Inclusion Criteria

All patients who have the RVAD placed as standard of care at the University of Utah Hospital following Right Ventricular Failure for any reason may be included in the study (after informed consent to collect patient data is obtained). These will be patients >18 years old who require RVAD support with the FDA approved CentriMag.

Exclusion Criteria

The CentriMag RVAS is only contraindicated in patients with primary coagulopathy or platelet disorders or an allergy or sensitivity to heparin and all alternative anticoagulants.

We will not include patients <18 years old.