PSR-CRHF: Enlighten Japan

Medtronic Japan0 个研究点目标入组 300 人开始时间: 待定最近更新: 2025年2月14日

试验速览

暂无简介。

•Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
•Patient has or is intended to receive or be treated with an eligible Medtronic product
•Patient is consented within the enrollment window of the therapy received

•Patient who is, or is expected to be, inaccessible for follow-up
•Participation is excluded by local law
•Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results

Freedom from major complications

时间窗: 2-years post implant

Characterize the freedom from major complications related to the Aurora EV-ICD System and/or procedure

Aurora EV-ICD major system and/or procedure related complication-free survival probability(time post-implant)
Patient demographics and baseline medical history
Device system revisions
Rate of abnormal battery depletion complications(time post-implant)
Patient deaths
Extracardiac pacing sensation
ATP with spontaneous arrhythmias
Asystole pacing
Sensing and detection
Defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia

发起方

Medtronic Japan