Monitors safety of MicroPort heart rhythm devices after they reach the market
Watches long-term safety of implanted heart rhythm devices in adults aged 18 to 90.
Plain-language title generated from the registry record
Registry title: Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Key facts
- Where
- Lisbon, PortugalSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT05694572, who can take part
Where in Portugal
- Hospital Santa Marta LisboaLisbon, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MicroPort CRM
- Trial code
- NCT05694572
- Record updated
- 17 January 2024
- Original description
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.Read full original descriptionShow less
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
Inclusion: 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.
Exclusion: 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.