Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices — PIANO  

Heart Failure Clinical Trial

Official title: Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Rhythm Disorder
• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

• NCT number: NCT05694572
• Study type: Observational [Patient Registry]
• Source: MicroPort CRM
• Contact: Hanan FAWAZ, MSC
• Phone: 33616531960
• Email: hanan.fawaz@crm.microport.com
• Status: Recruiting
• Start date: October 30, 2023
• Completion date: June 15, 2031