Cardiac Rhythm DisorderHeart FailureSudden Cardiac Death
Investigational drug(s) / intervention(s)
Implantation of a CIED
Implantation of a CIED: Implantation of a CIED
Study summary
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:
1. 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
2. Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
3. Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
4. Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible to be enrolled in the study:
1. Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
2. Life expectancy less than 1 year
3. Currently enrolled in an active study of MicroPort CRM
Primary outcome measure(s)
Chronic complication free rate of MicroPort CRM market-released system — Through study duration, an average of 5 years Complications are defined as device-related reinterventions or deaths
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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