NCT05694572 Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
| NCT ID | NCT05694572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MicroPort CRM |
| Condition | Cardiac Rhythm Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2031-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2023-10-30 with a primary completion date of 2031-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Yann POEZEVARA, MSc
STUDY DIRECTOR
MicroPort CRM
Frequently Asked Questions
Who can join the NCT05694572 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Cardiac Rhythm Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05694572 currently recruiting?
Yes, NCT05694572 is actively recruiting participants. Contact the research team at hanan.fawaz@crm.microport.com for enrollment information.
Where is the NCT05694572 trial being conducted?
This trial is being conducted at Lisbon, Portugal.
Who is sponsoring the NCT05694572 clinical trial?
NCT05694572 is sponsored by MicroPort CRM. The principal investigator is Yann POEZEVARA, MSc at MicroPort CRM. The trial plans to enroll 2,500 participants.