January 1, 2008
Two groups of patients will take part in the PARTNER trial.
The surgical arm of the trial will consist of patients with severe aortic stenosis who are considered at high-risk because of their disease, but who nevertheless are candidates for conventional open-heart surgery. The other arm will consist of patients with severe aortic stenosis who are considered inoperable because they are unlikely to survive open-heart surgery.
In the surgical arm, patients will be randomly assigned to receive either the transcatheter valve or to undergo a conventional valve replacement in which the chest cavity is opened and a new valve is sewn into the heart. In the other arm of the trial, patients will be randomly assigned to receive either the transcatheter valve or appropriate medical therapy.
Success in the surgical arm is achieved if the clinical results demonstrate that the transcatheter heart valve is not statistically inferior to conventional open-heart surgery. The clinical results of the other arm need to demonstrate that the transcatheter heart valve is statistically superior to medical management.