A randomized, controlled trial of PHVR in adults with aortic stenosis is ongoing at 26 sites in the United States, Canada, and Germany. The PARTNER (Placement of AoRtic TraNscathetER) valve trial (ClinicalTrials.gov registration number: NCT00530894), sponsored by Edwards Lifesciences, was initiated in April 2007 and has a completed enrollment of approximately 1040 participants (26). In this 2-group study, participants with symptomatic, severe, aortic stenosis and a Society of Thoracic Surgeons Predicted Risk of Mortality risk score of 10 or more who are candidates for SAVR were randomly allocated to receive the Edwards SAPIEN transcatheter heart valve (by means of the transfemoral or transapical approach) or undergo SAVR (cohort A); participants who are not candidates for SAVR (defined as operative mortality or serious, irreversible morbidity of 50% or more) were randomly allocated to the Edwards SAPIEN transcatheter heart valve or medical management, including balloon aortic valvuloplasty, as indicated (cohort B; 350 patients). The primary outcome measure is 1-year survival; secondary outcomes include major adverse cardiac or cerebrovascular events and other safety events, functional and quality-of-life improvement, evidence of prosthetic valve dysfunction, and rehospitalization. Preliminary results of cohort B, which completed enrollment in March 2009, are expected to be presented at the Transcatheter Cardiovascular Therapeutics meeting in Washington, DC, in September 2010. This trial comparing PHVR with either conventional heart surgery or medical management will be critical in evaluating the relative safety and efficacy of PHVR for both surgical and nonsurgical candidates.