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A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)

Aortic Stenosis Clinical Trial

Official title:
A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis

Clinical Trial Summary

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.

Clinical Trial Description

1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. Data will be collected from all patients for up to five years following the index valve replacement procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02903420
Study type Interventional
Source Edwards Lifesciences
Contact
Status Active, not recruiting
Phase N/A
Start date September 2016
Completion date January 2026
View Details
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