Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04075084




Registration number
NCT04075084
Ethics application status
Date submitted
8/08/2019
Date registered
30/08/2019
Date last updated
17/01/2024

Titles & IDs
Public title
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Scientific title
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Secondary ID [1] 0 0
HS061
Universal Trial Number (UTN)
Trial acronym
BIOSTREAM-ICM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tachycardia 0 0
Atrial Fibrillation 0 0
Syncope 0 0
Bradycardia 0 0
Cryptogenic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to diagnosis
Timepoint [1] 0 0
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Secondary outcome [1] 0 0
Insertion procedure and success
Timepoint [1] 0 0
It is considered that all patients are enrolled and subsequently inserted with the investigational device within 2 years after study start, i.e. until October 2021. Exchanges will be also considered for analysis

Eligibility
Key inclusion criteria
- Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)

- Patient is able to understand the nature of the registry and to provide written
informed consent.

- Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home
Monitoring concept.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient is pregnant or breast feeding.

- Patient is less than 18 years old.

- Patient is participating in another interventional clinical investigation other than
the submodules of BIO|STREAM.ICM

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2028
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Integral Health - Adelaide
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Bordeaux
Country [2] 0 0
France
State/province [2] 0 0
Brest
Country [3] 0 0
France
State/province [3] 0 0
Caen
Country [4] 0 0
France
State/province [4] 0 0
Chambray-lès-Tours
Country [5] 0 0
France
State/province [5] 0 0
Clermont-Ferrand
Country [6] 0 0
France
State/province [6] 0 0
Pessac Cedex
Country [7] 0 0
France
State/province [7] 0 0
Strasbourg
Country [8] 0 0
Germany
State/province [8] 0 0
Ahaus
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Nauheim
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Neustadt An Der Saale
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin-Mitte
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin-Steglitz
Country [13] 0 0
Germany
State/province [13] 0 0
Dresden
Country [14] 0 0
Germany
State/province [14] 0 0
Erfurt
Country [15] 0 0
Germany
State/province [15] 0 0
Herford
Country [16] 0 0
Germany
State/province [16] 0 0
Leipzig
Country [17] 0 0
Germany
State/province [17] 0 0
München
Country [18] 0 0
Italy
State/province [18] 0 0
Castrovillari
Country [19] 0 0
Italy
State/province [19] 0 0
Torino
Country [20] 0 0
Latvia
State/province [20] 0 0
Riga
Country [21] 0 0
Portugal
State/province [21] 0 0
Guimarães
Country [22] 0 0
Portugal
State/province [22] 0 0
Lisboa
Country [23] 0 0
Spain
State/province [23] 0 0
Erandio
Country [24] 0 0
Spain
State/province [24] 0 0
Fuenlabrada
Country [25] 0 0
Spain
State/province [25] 0 0
Vitoria-Gasteiz
Country [26] 0 0
Switzerland
State/province [26] 0 0
Wetzikon
Country [27] 0 0
Switzerland
State/province [27] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This registry is performed for the long-term assessment of outcome, performance and residual
safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up.
In addition, this registry is set up in a way that it may also be used as a platform for
submodules to investigate additional scientific and regulatory aspects while minimizing the
additional effort for the investigational sites and patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04075084
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sabrina Hoche, Dr.
Address 0 0
Country 0 0
Phone 0 0
+49 30 68905
Fax 0 0
Email 0 0
biomonitor-registry@biotronik.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04075084