Cryptogenic Stroke, Syncope
Conditions
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.
Interventions
None listed
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SADE free rate | 3 month | Serious adverse device effect (SADE) free rate related to the BIOMONITOR system |
Other
| Measure | Time frame | Description |
|---|---|---|
| R-wave amplitude | 3 month | Assessment of R-wave Amplitude (Millivolt) detected by the BIOMONITOR and transmitted via Home Monitoring |
| Noise burden | 3 month | Assessment of electrical noise burden (%) detected by the BIOMONITOR and transmitted via Home Monitoring |
| Ventricular rate | 3 month | Assessment of mean ventricular rate (bpm) detected by the BIOMONITOR and transmitted via Home Monitoring |
Countries
France
Outcome results
None listed