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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03366545




Registration number
NCT03366545
Ethics application status
Date submitted
27/11/2017
Date registered
7/12/2017
Date last updated
11/02/2019

Titles & IDs
Public title
Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
Scientific title
Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
Secondary ID [1] 0 0
CR021
Universal Trial Number (UTN)
Trial acronym
BIO|STREAM HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Cardiac Resynchronization Therapy (CRT)

Treatment: Devices: Cardiac Resynchronization Therapy (CRT)
Observation and documentation of routine care for CRT patients

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of cardiovascular adverse events - Number of unplanned hospitalization for cardiovascular cause
Timepoint [1] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [2] 0 0
Number of patient deaths - Number of all-cause mortality
Timepoint [2] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [3] 0 0
Number of all cause hospitalization - Number of all cause hospitalization
Timepoint [3] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [4] 0 0
Number of patients with worsening of heart failure events - Number of unplanned hospitalization for worsening of heart failure
Timepoint [4] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [5] 0 0
Number of patients with cerebrovascular events - Number of cerebrovascular events requiring hospitalization
Timepoint [5] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [6] 0 0
Number of all adverse device effects - Number of all adverse device effects
Timepoint [6] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [7] 0 0
Number of all device deficiencies - Number of all device deficiencies
Timepoint [7] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [8] 0 0
Assessment of patients benefit from CRT - Documentation of NYHA classification [I-IV]
Timepoint [8] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [9] 0 0
Number of patient deaths with cardiovascular cause - Number of patient deaths with cardiovascular cause
Timepoint [9] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [10] 0 0
Documentation of LVEF - Left ventricular ejection fraction [%]
Timepoint [10] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [11] 0 0
Documentation of LVESV - Left ventricular end-systolic volume [ml]
Timepoint [11] 0 0
throughout study duration, average of 3.5 years; annual evaluations

Eligibility
Key inclusion criteria
- Planned implantation of or upgrade to a CRT system for treatment according to the
intended use

- Patient is able to understand the nature of the registry and has provided written
informed consent

- Patient is willing and able to use the CardioMessenger and accepts the Home
Monitoring® concept

- Remote monitoring using the Home Monitoring® platform is planned for the patient
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Standard contraindication for CRT

- Already implanted with CRT System

- Planned Implantation of a BIOTRONIK DX ICD lead

- Age < 18 years

- Participation in another interventional clinical investigation other than the
registry-based trials of BIO|STREAM.HF

- Pregnant or breastfeeding

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Westmead Private Hosptial - Westmead
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Elizabeth Vale
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
St. Polten
Country [3] 0 0
Belgium
State/province [3] 0 0
Bonheiden
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
Belgium
State/province [5] 0 0
Liège
Country [6] 0 0
Czechia
State/province [6] 0 0
Olomouc
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha
Country [8] 0 0
Czechia
State/province [8] 0 0
Ceské Budejovice
Country [9] 0 0
France
State/province [9] 0 0
Lorient
Country [10] 0 0
France
State/province [10] 0 0
Lyon
Country [11] 0 0
France
State/province [11] 0 0
Marseille
Country [12] 0 0
France
State/province [12] 0 0
Périgueux
Country [13] 0 0
France
State/province [13] 0 0
Vannes
Country [14] 0 0
Germany
State/province [14] 0 0
Sachsen
Country [15] 0 0
Germany
State/province [15] 0 0
Bad Berka
Country [16] 0 0
Germany
State/province [16] 0 0
Bad Oeynhausen
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Buchholz
Country [19] 0 0
Germany
State/province [19] 0 0
Erlangen
Country [20] 0 0
Germany
State/province [20] 0 0
Gießen
Country [21] 0 0
Germany
State/province [21] 0 0
Güstrow
Country [22] 0 0
Germany
State/province [22] 0 0
Jena
Country [23] 0 0
Germany
State/province [23] 0 0
Lingen
Country [24] 0 0
Germany
State/province [24] 0 0
Lübeck
Country [25] 0 0
Germany
State/province [25] 0 0
Merseburg
Country [26] 0 0
Germany
State/province [26] 0 0
Minden
Country [27] 0 0
Germany
State/province [27] 0 0
München
Country [28] 0 0
Germany
State/province [28] 0 0
Münster
Country [29] 0 0
Germany
State/province [29] 0 0
Neuss
Country [30] 0 0
Germany
State/province [30] 0 0
Oldenburg
Country [31] 0 0
Germany
State/province [31] 0 0
Würzburg
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Pécs
Country [34] 0 0
Israel
State/province [34] 0 0
Be'er Sheva
Country [35] 0 0
Israel
State/province [35] 0 0
H_olon
Country [36] 0 0
Israel
State/province [36] 0 0
Jerusalem
Country [37] 0 0
Israel
State/province [37] 0 0
Petach Tikva
Country [38] 0 0
Israel
State/province [38] 0 0
Re?ovot
Country [39] 0 0
Israel
State/province [39] 0 0
Tel HaShomer
Country [40] 0 0
Latvia
State/province [40] 0 0
Riga
Country [41] 0 0
Malaysia
State/province [41] 0 0
Kuala Lumpur
Country [42] 0 0
Poland
State/province [42] 0 0
Warsaw
Country [43] 0 0
Portugal
State/province [43] 0 0
Carnaxide
Country [44] 0 0
Portugal
State/province [44] 0 0
Lisboa
Country [45] 0 0
Portugal
State/province [45] 0 0
Porto
Country [46] 0 0
Slovakia
State/province [46] 0 0
Banská Bystrica
Country [47] 0 0
Slovakia
State/province [47] 0 0
Bratislava
Country [48] 0 0
Slovakia
State/province [48] 0 0
KoŇ°ice
Country [49] 0 0
South Africa
State/province [49] 0 0
Pretoria
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Donostia
Country [52] 0 0
Spain
State/province [52] 0 0
Málaga
Country [53] 0 0
Switzerland
State/province [53] 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
The registry is primarily designed to assess outcome, efficacy and residual safety aspects of
CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the
observation of the patient status should help to find possible predictors for HF events and
to identify areas of improvement for CRT and for CRT device settings.
Trial website
https://clinicaltrials.gov/show/NCT03366545
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
Andreas Peth, Dr.
Address 0 0
Country 0 0
Phone 0 0
+493068905
Fax 0 0
Email 0 0
bio-stream-hf@biotronik.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable