Overview
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
Description
PIANO Post Market Surveillance (PMS) investigation will cover MicroPort CRM systems CEmarket and released since 2018.
Continuous monitoring of MicroPort CRM market-released systems will also enable to:
- confirm the safety and performance of the device throughout the study duration
- identify previously unknown side-effects and monitoring the identified side-effects and contraindications,
- identify and analyse emergent risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio
- identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct
Eligibility
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