透析患者における経カテーテル大動脈弁の臨床試験（日本）

基本情報

NCT ID

NCT02903420

ステータス

実施中（募集終了）

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

38

治験依頼者名

Edwards Lifesciences

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)