BIO|STREAM.ICM France

Completed

• Conditions: Syncope; Cryptogenic Stroke

• Registration Number: NCT04206774
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-20
• Study Start: 2020-03-13
• Primary Completion: 2021-07-01
• Study Completion: 2021-12-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SADE free rate	3 month	Serious adverse device effect (SADE) free rate related to the BIOMONITOR system

Trial Locations

Locations (3)

CH Villefranche Sur Saone; 🇫🇷 Gleizé, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, Caen, France

CHRU de Tours, Hopital Trousseau; 🇫🇷 Tours, France