NCT04075084

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,400 (estimated)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.

Conditions

• Tachycardia
• Atrial Fibrillation
• Syncope
• Bradycardia
• Cryptogenic Stroke

Timeline

• Start date: 2019-10-28
• Primary completion: 2027-05-30
• Completion: 2027-08-30
• First posted: 2019-08-30
• Last updated: 2025-10-01

Locations

31 sites across 9 countries: Australia, Czechia, France, Germany, Italy, Latvia, Portugal, Spain, Switzerland