低リスク患者におけるメドトロニックEvolut経カテーテル大動脈弁置換術

基本情報

NCT ID

NCT02701283

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

2,223

治験依頼者名

Medtronic Cardiovascular

概要

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

対象疾患

介入

依頼者（Sponsor）

実施施設 (8)