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

Biotronik

Status: Enrolling

Conditions: Bradycardia; Syncope; Atrial Fibrillation; Tachycardia; Cryptogenic Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT04075084

HS061

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)
• Patient is able to understand the nature of the registry and to provide written informed consent.
• Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion criteria

• Patient is pregnant or breast feeding.
• Patient is less than 18 years old.
• Patient is participating in another interventional clinical investigation other than the submodules of BIO|STREAM.ICM