READINESS TEST OF IMPLANTABLE TOTALLY ARTIFICIAL HEART

Pennsylvania State Univ Hershey Med Ctr, Hershey PA

Investigators

Linked publications & trials

Abstract

The purpose of this program are to complete the development of electrically powered, totally implantable artificial heart (TAH) systems and establish the reliability, performance and manufacturability of these TAH systems as a prerequisite to consideration for an NHLBI Clinical Trial. Phase I (3 years; up to four contracts) comprises design completion, demonstration of manufacturability, performance testing in animals and demonstration of the contractor's capability to begin Phase II device readiness testing. Phase II (4 years; less than four contracts) will provide support for those contractors who successfully complete Phase I and are judged meritorious by peer-review. Phase II consists of in vitro reliability and in vivo animal testing of tether-free implantable total artificial heart systems.