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
92
Hôpital Gabriel Montpied
Clermont-Ferrand, Caen, France
CH Villefranche Sur Saone
Gleizé, France
CHRU de Tours, Hopital Trousseau
Tours, France
SADE free rate
Serious adverse device effect (SADE) free rate related to the BIOMONITOR system
Time frame: 3 month
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