Clinical Trials in Portugal / NCT05694572
Recruiting Observational

Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

NCT05694572 · tracked via the Priya Life Science Portugal tracker
Phase
Observational
Started
2023-10-30
Last updated
2024-01-17

Condition(s) studied

Cardiac Rhythm DisorderHeart FailureSudden Cardiac Death

Investigational drug(s) / intervention(s)

Implantation of a CIED

Implantation of a CIED: Implantation of a CIED

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Santa Marta Lisboa Lisbon Portugal Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05694572 on ClinicalTrials.gov ↗ ← All trials in Portugal