Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Recruiting now

Conditions studied: Cardiac Rhythm Disorder, Heart Failure, Sudden Cardiac Death

In brief

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

Key facts

Study ID

NCT05694572

Run by

MicroPort CRM

People needed

2500

Starts

2023-10-30

Expected to finish

2031-06-15

Last updated by the study team

2024-01-17

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital Santa Marta Lisboa — Lisbon, Portugal (enrolling)

Full record on ClinicalTrials.gov

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