NCT04206774

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

December 12, 2019

Last Update Submit

January 3, 2022

Conditions

SyncopeCryptogenic Stroke

Outcome Measures

Primary Outcomes (1)

  • SADE free rate

    Serious adverse device effect (SADE) free rate related to the BIOMONITOR system

    3 month

Other Outcomes (3)

  • R-wave amplitude

    3 month

  • Noise burden

    3 month

  • Ventricular rate

    3 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Life-expectancy is less than 3 months
  • Already implanted with BIOMONITOR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Gabriel Montpied

Clermont-Ferrand, Caen, 14000, France

Location

CH Villefranche Sur Saone

Gleizé, France

Location

CHRU de Tours, Hopital Trousseau

Tours, 37044, France

Location

MeSH Terms

Conditions

SyncopeIschemic Stroke

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Romain ESCHALIER, Pr.

    Hôpital Gabriel Montpied

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 20, 2019

Study Start

March 13, 2020

Primary Completion

July 1, 2021

Study Completion

December 16, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)