DURAHEART

Title: DURAHEART – Evaluation of the Safety and Effectiveness of the DuraHeart^TM Left Ventricular Asssit System in Patients Awaiting Transplantation

Study Sponsor: Terumo Inc.

Principal Investigator: Nader Moazami, MD 

Study Synopsis: The purpose of this study is to evaluate the safety and effectiveness of the DuraHeart^TM Left Ventricular Assist System in patients with end stage congestive heart failure (CHF) who are awaiting heart transplantation. Since a failing heart cannot pump enough blood to the body, this investigational device helps take on the additional work load. It consists of several components including a pump and controller. The pump is surgically implanted into the upper abdomen. This connects to a pump cable that exits the skin and connects to the controller. The controller is a small device that acts like the "brain" of the pump and is worn outside the body similar to a backpack. This study will recruit up to 20 patients who are actively on the heart transplant list at Abbott Northwestern Hospital.  

How do I qualify?  Patients may qualify if they are on the UNOS transplant list and classified 1A or 1B.

Status:  Open for enrollment

Who do I contact for more information? Charlene Boisjolie, RN 612.863.3974, Karen Meyer, RN 612.863.5855 or call research 612.863.3980