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NCT04206774 Clinical Trial

BIO|STREAM.ICM France

Syncope Clinical Trial

Official title:
BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04206774
Other study ID # HS066
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2020
Est. completion date December 16, 2021

Study information
Verified date January 2022
Source Biotronik SE & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date December 16, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France Hôpital Gabriel Montpied Clermont-Ferrand Caen
France CH Villefranche Sur Saone Gleizé
France CHRU de Tours, Hopital Trousseau Tours

Sponsors (1)
Lead Sponsor Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Other R-wave amplitude Assessment of R-wave Amplitude (Millivolt) detected by the BIOMONITOR and transmitted via Home Monitoring 3 month
Other Noise burden Assessment of electrical noise burden (%) detected by the BIOMONITOR and transmitted via Home Monitoring 3 month
Other Ventricular rate Assessment of mean ventricular rate (bpm) detected by the BIOMONITOR and transmitted via Home Monitoring 3 month
Primary SADE free rate Serious adverse device effect (SADE) free rate related to the BIOMONITOR system 3 month
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