Prospective, Single Arm, multi center registry study of subjects with a Confirm Rx Insertable Cardiac Monitor SMART Registry. - Confirm Rx SMART Registry

St Jude Medical Abbott0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Eligible subjects will meet all of the following:
•1. Have an approved indication for continuous arrhythmia monitoring with an ICM.
•2. Have a cellular phone or the ability or willing to use a St. Jude Medical mobile transmitter that is compatible with the MyMerlin• App and able to communicate with the Confirm RxTM ICM device. If a subject doesnâ??t have a cell phone or loses their cell phone, then the site can provide a St. Jude Medical mobile transmitter to the subject. The study will not provide cell phones.
•3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
•4. Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.

•Subjects will be excluded if they meet any of the following:
•1. Subject is implanted with or indicated for implant with a pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
•2. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by the sponsor, during the course of this clinical study.
•3. Have a life expectancy of less than 1 year due to any condition.
•4. Have a previous ICM placement.

发起方

St Jude Medical Abbott