J-Valve経大腿動脈ピボタル研究

基本情報

NCT ID: NCT06455787
ステータス: 募集中
試験のフェーズ: 該当なし
試験タイプ: 介入
目標被験者数: 194
治験依頼者名: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

概要

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

対象疾患

大動脈弁逆流症大動脈弁疾患混合型

介入

J-Valve Transfemoral (TF) System(DEVICE)

依頼者（Sponsor）

Cardiovascular Research Foundation, New York(OTHER)

Jc Medical, Inc., An Affiliate Of Edwards Lifesciences(INDUSTRY)

Minneapolis Heart Institute Foundation(OTHER)

実施施設 (2)

慶應義塾大学病院

Tokyo, Shinjuku-Ku, Japan(RECRUITING)

順天堂大学医学部附属順天堂医院

Tokyo, Bunkyo-ku, Japan(RECRUITING)