Actively Recruiting
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Led by MicroPort CRM · Updated on 2024-01-17
2500
Participants Needed
1
Research Sites
397 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
CONDITIONS
Official Title
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject implanted with a MicroPort CRM system: ENO, TEO, OTO, ALIZEA, BOREA, or CELEA pacemaker single or dual chamber implanted after January 1, 2020 with at least one XFINE or VEGA pacing lead
- Subject implanted with ULYS, EDIS ICD single or dual chamber system with an INVICTA defibrillation lead; optional additional XFINE or VEGA atrial pacing lead
- Subject implanted with GALI CRT-D with an INVICTA defibrillation lead; optional NAVIGO left ventricular pacing lead
- Subject implanted with GALI SONR CRT-D with an INVICTA defibrillation lead and either NAVIGO left ventricular or SONRTIP atrial pacing lead
- Subject implanted with future generation MicroPort CRM PM, ICD, or CRT-D devices with existing or future generation MicroPort CRM leads
- Subject equipped with a Remote Monitoring System if implanted with ICD or CRT-D system
- Subject followed yearly by investigational site through in-clinic or remote visits
- Subject reviewed, signed, and dated the Informed Consent Form as applicable per country regulations
You will not qualify if you...
- Age less than 18 years or more than 90 years at time of inclusion
- Incapacitated, under guardianship, or detained
- Life expectancy less than 1 year
- Currently enrolled in an active MicroPort CRM study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Santa Marta Lisboa
Lisbon, Portugal
Actively Recruiting
Research Team
H
Hanan FAWAZ, MSC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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