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.
Key facts
- Who runs it
- MicroPort CRM
- Where
- Lisbon, PortugalSee the site
- Trial code
- Registry title
- Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
- Status
- Recruiting
- People taking part
- 2,500 people, planned
- Started
- 30 Oct 2023
- Expected to end
- 15 Jun 2031
- Type of study
- Observational, 3 groups
- Treatments tested
- Implantation of a CIED
- Record updated
- 17 January 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who already have a MicroPort CRM pacemaker, defibrillator (ICD) or CRT-D heart device with the listed leads. Its aim is to check the long-term safety of these devices.
- Age
- 18 to 90 years
- Sex
- All sexes can join.
- Earlier treatment
- Must already have one of the listed MicroPort CRM devices implanted. Pacemakers must have been implanted after 01 January 2020, with at least one XFINE or VEGA pacing lead.
Main reasons for not taking part
- Younger than 18 or older than 90 years
- Life expectancy less than 1 year
- Currently in another active MicroPort CRM study
- Unable to decide for themselves, under guardianship or kept in detention
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Portugal
- Hospital Santa Marta LisboaLisbon, PortugalContact: Mario Olivera, MDTaking people
About the trial
What the trial wants to find out
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
The 3 groups in the trial
- Pacemaker system
Patients implanted with ENO or ALIZEA family pacing systems
Treatment: Implantation of a CIED
- ICD system
Patients implanted with ULYS family ICD systems
Treatment: Implantation of a CIED
- CRT-D system
Patients implanted with GALI family CRT-D systems
Treatment: Implantation of a CIED
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
- Plain-language title
- Monitors safety of MicroPort heart rhythm devices after they reach the marketGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05694572, who can take part
- Record updated
- 17 January 2024