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Recruiting NCT05694572

Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Trial Parameters

Condition Cardiac Rhythm Disorder
Sponsor MicroPort CRM
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,500
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2023-10-30
Completion 2031-06-15
Interventions
Implantation of a CIED

Brief Summary

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

Eligibility Criteria

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

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