BIO|STREAM.ICM France | NCT04206774

Studies
BIO|STREAM.ICM France

NCT04206774

Sponsor

Biotronik SE & Co. KG

Status

Completed

Last Update Posted

Jan 4, 2022Actual

Enrollment

92Actual

Phase

Not provided

Conditions

Syncope
Cryptogenic Stroke

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2020Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Dec 16, 2021Actual

First Submitted Date

Dec 12, 2019

First Submission Date that Met QC Criteria

Dec 18, 2019

First Posted Date

Dec 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2022

Last Update Posted Date

Jan 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SADE free rate	Serious adverse device effect (SADE) free rate related to the BIOMONITOR system	3 month

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
R-wave amplitude	Assessment of R-wave Amplitude (Millivolt) detected by the BIOMONITOR and transmitted via Home Monitoring	3 month
Noise burden	Assessment of electrical noise burden (%) detected by the BIOMONITOR and transmitted via Home Monitoring

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Romain ESCHALIER, Pr.	Hôpital Gabriel Montpied	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Gabriel Montpied		Clermont-Ferrand	Caen	14000	France
CH Villefranche Sur Saone

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013575	Syncope
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D014474	Unconsciousness
D003244	Consciousness Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided