NCT05694572

Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: MicroPort CRM · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiac Rhythm Disorder
• Heart Failure
• Sudden Cardiac Death

Interventions

Type	Name	Description
DEVICE	Implantation of a CIED	Implantation of a CIED

Timeline

• Start date: 2023-10-30
• Primary completion: 2031-06-15
• Completion: 2031-06-15
• First posted: 2023-01-23
• Last updated: 2024-01-17

Locations

1 site across 1 country: Portugal