|OCS Heart Trial, PROCEED II|
Pivotal Trial for Heart Transplantation
PROCEED II is a global clinical trial that compares standard cold storage of donor hearts to warm oxygenated blood perfusion using the Organ Care System.
PROCEED II Trial Design
128 patients may participate in the trial. There is a 50% chance that a participant will receive a heart transported using the OCS and a 50% chance the heart will be transported under cold storage conditions. The success of the trial will be measured by primary and secondary endpoints.
Cumulative OCS Clinical Experience
As of October 2011, there have been 125 OCS HEART transplants on both a commercial and trial basis in Europe and on a trial basis in the U.S.
INVESTIGATIONAL DEVICE: Not commercially available in the U.S.