An observational study in Syncope and Cryptogenic Stroke, sponsored by Biotronik SE & Co. KG. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by Biotronik SE & Co. KG · Observational
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.
226 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's enrollment of 92 is below the median of 221 across 91 observational studies indexed under Syncope.
Browse Syncope studies →Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated in French investigation sites, with an indication for Insertable Cardiac Monitors (ICM) in accordance with the European guidelines and followed with the BIOTRONIK Home Monitoring® system.
Exclusion Criteria:
SADE free rate
Serious adverse device effect (SADE) free rate related to the BIOMONITOR system
Time frame: 3 month
R-wave amplitude
Assessment of R-wave Amplitude (Millivolt) detected by the BIOMONITOR and transmitted via Home Monitoring
Time frame: 3 month
Noise burden
Assessment of electrical noise burden (%) detected by the BIOMONITOR and transmitted via Home Monitoring
Time frame: 3 month
Ventricular rate
Assessment of mean ventricular rate (bpm) detected by the BIOMONITOR and transmitted via Home Monitoring
Time frame: 3 month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Biotronik SE & Co. KG