The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
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
Study Type
OBSERVATIONAL
Enrollment
2,500
Implantation of a CIED
Hospital Santa Marta Lisboa
Lisbon, Portugal
RECRUITINGChronic complication free rate of MicroPort CRM market-released system
Complications are defined as device-related reinterventions or deaths
Time frame: Through study duration, an average of 5 years
Acute complication free rate
Complications are defined as device-related reinterventions or deaths
Time frame: Up to 3 months post-implant
Overall complication free rate
Complications are defined as device-related reinterventions or deaths
Time frame: Through study duration, an average of 5 years
Annual complication free rate
Complications are defined as device-related reinterventions or deaths
Time frame: Through study duration, an average of 1 year
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