Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Ki vehet részt

• Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:
• Subject implanted with one of the following MicroPort CRM market-released system:; ENO, TEO, OTO, ALIZEA, BOREA, or CELEA PM single chamber (SR) or dual chamber (DR) implanted after 01 January 2020 in combination with at least one XFINE or VEGA pacing lead; ULYS, EDIS ICD single chamber (VR) or dual chamber (DR) system in combination with an INVICTA defibrillation lead. Additional XFINE or VEGA atrial pacing lead is optional; GALI CRT-D implanted in combination with an INVICTA defibrillation lead. Additional NAVIGO left ventricular pacing lead is optional; GALI SONR CRT-D in combination with an INVICTA defibrillation lead and with either a NAVIGO left ventricular or a SONRTIP atrial pacing lead; Future generation of market approved MicroPort CRM PM, ICD or CRT-D device associated with existing or future generation of MicroPort CRM lead
• Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
• Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
• Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation

Ki nem vehet részt

• Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
• Subjects who meet any of the following criteria are not eligible to be enrolled in the study:
• Life expectancy less than 1 year
• Currently enrolled in an active study of MicroPort CRM