RecruitingNCT05694572

Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Sponsor

MicroPort CRM

Enrollment

2,500 participants

Start Date

Oct 30, 2023

Study Type

OBSERVATIONAL

Conditions

The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.

Min Age: 18 YearsMax Age: 90 Years

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

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