BIO|STREAM.ICM France

Biotronik

Status: Completed

Conditions: Syncope; Cryptogenic Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT04206774

HS066

Details and patient eligibility

About

The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system

Full description

The BIO|STREAM.ICM submodule will recruit a subset of patients with syncope with uncertain origin and cryptogenic stroke without history of atrial arrhythmia from the existing population enrolled in the BIO|STREAM.ICM registry. The submodule study is designed to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR System.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for ICM device in accordance with the European guidelines: syncope with uncertain origin or cryptogenic stroke without history of atrial arrhythmia
• Enrolled in the BIO|STREAM.ICM registry

Exclusion criteria

• Life-expectancy is less than 3 months
• Already implanted with BIOMONITOR