Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
brief summary
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
detailed description
PIANO Post Market Surveillance (PMS) investigation will cover MicroPort CRM systems CE- market 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