A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Protocol Amendment History
8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2016-09-12; most recent amendment 2024-09-20.
Status change: Recruiting → Active, Not Recruiting2018-06-17
Status change: Not Yet Recruiting → Recruiting2017-02-07