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ID04075084

Long-Term Observation of Patients Using BIOTRONIK Implantable Cardiac Monitors ICMs in Routine Care

Led by Biotronik SE & Co. KG · Updated on 2025-10-01

1400

Participants Needed

31

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the long-term outcomes, performance, and ongoing safety of the BIOMONITOR III and its possible successors in everyday clinical use. It focuses on patients with conditions such as tachycardia, atrial fibrillation, syncope, bradycardia, or cryptogenic stroke. The study is designed as an observational registry, allowing additional scientific investigations with minimal extra effort for participants and study sites. Participants will receive a BIOTRONIK Implantable Cardiac Monitor ICM and will use the CardioMessenger device to support the BIOTRONIK Home Monitoring system. The registry monitors patients under routine clinical care without introducing experimental treatments or interventions. Data collection includes the insertion procedure and success rate of the device, as well as the time taken to reach a relevant diagnosis starting from device implantation. Throughout the study, participants will be observed during their regular clinical care visits. Researchers will collect information on device performance, safety, and diagnostic timelines. The study will continue until August 30, 2027, tracking patient outcomes over this extended period. Participation involves consenting to the use of home monitoring technology and agreeing to data collection related to the implanted device and clinical events.

CONDITIONS

Brief Title

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

Research Team

S

Sabrina Hoche, Dr.

D

Dörte Vossmeyer, Dr.

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