3T MRI CIEDの市販後調査

基本情報

NCT ID

NCT02969395

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

41

治験依頼者名

Medtronic

概要

The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

対象疾患

依頼者（Sponsor）