BIO|STREAM.ICM France

N/ACompletedNCT04206774

Biotronik SE & Co. KG92 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Syncope Cryptogenic Stroke

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Hôpital Gabriel Montpied

Clermont-Ferrand, Caen, France

CH Villefranche Sur Saone

Gleizé, France

CHRU de Tours, Hopital Trousseau

Tours, France

Outcomes

Primary Outcomes

SADE free rate

Serious adverse device effect (SADE) free rate related to the BIOMONITOR system

Time frame: 3 month

Data from ClinicalTrials.gov

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