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日本における胸腔内インピーダンス測定による心不全患者の体液状態モニタリング(J-HomeCARE II)

基本情報

NCT ID
NCT01221649
ステータス
完了
試験のフェーズ
第4相
試験タイプ
介入
目標被験者数
198
治験依頼者名
Biotronik Japan, Inc.

概要

The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. In future, this will allow for automatic early detection of imminent decompensation at a presymptomatic stage and immediate initialization of clinical meaningful therapeutic interventions preventing heart failure (HF) related hospitalizations. The aim of this investigation is to record long-term impedance trends in heart failure patients with and without heart failure related events (hospitalizations due to acute decompensation) in order to develop algorithms for device-based early detection and warning of HF deterioration accompanied by pulmonary congestion.

対象疾患

Heart FailureArrhythmias, Cardiac

介入

ICD/CRT-D(DEVICE)

依頼者(Sponsor)

Biotronik Japan(INDUSTRY)

実施施設 (4)

広島市医師会運営・安芸市民病院

Hiroshima, Hiroshima, Japan

東京女子医科大学病院

Tokyo, Tokyo, Japan

小倉記念病院

Kitakyushu, Fukuoka, Japan

函館赤十字病院

Ise, Mie-ken, Japan