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ワンホスピタル臨床サービスプロジェクト

基本情報

NCT ID
NCT01007474
ステータス
取り下げ
試験のフェーズ
-
試験タイプ
観察
目標被験者数
0
治験依頼者名
Medtronic Italia

概要

The One Hospital ClinicalService Project is an integrated system composed by a network of International Hospital Departments, a clinical data repository and a shared environment for the collection, management, analysis and reporting of clinical and diagnostics data from patients treated by Medtronic therapies or patients wearing Medtronic implantable devices used within their intended use. The One Hospital ClinicalService is composed by a suite of systematic, data-guided activities designed to bring about immediate improvements in health delivery in particular settings. Data are prospectively collected. An independent committee of physicians prospectively identifies key clinical questions on a yearly basis for development of quality improvement activities, analyses and publications. A charter, approved by Hospital Istitutional Review Boards or other Hospital entities, assigns the ownership of data to the centers and governs the conduct of the project and the relationship of the scientific committee and Medtronic. Hospital is the data controller, while Medtronic is the data processor on behalf of the Hospital. Data collected for quality improvement purposes may be mined to perform clinical research.

対象疾患

Arrhythmias, CardiacBradycardiaSyncope

介入

Implantable Cardioverter-Defibrillator (ICD)(DEVICE)
Implantable Pacemaker Generator (IPG)(DEVICE)
Implantable Loop Recorder (ILR)(DEVICE)
Cardiac Resynchronization Therapy-Defibrillator (CRT-D)(DEVICE)
Implantable devices working as neurostimulators, stents, spinal/bone devices or other applications(DEVICE)

依頼者(Sponsor)

実施施設 (5)

東京科学大学病院

Bunkyō-Ku, Tokyo, Japan

香川大学医学部附属病院

Kagawa, Japan

栃木県済生会宇都宮病院

Kawaguchi, Japan

医療法人澄心会 豊橋ハートセンター

Toyohashi, Japan

大阪大学医学部附属病院

Suita, Osaka, Japan