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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03366545
Ethics application status
Date submitted
27/11/2017
Date registered
8/12/2017

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
Timepoint [1] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [2] 0 0
Number of patient deaths
Timepoint [2] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [3] 0 0
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
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
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
Timepoint [6] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [7] 0 0
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
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
Timepoint [9] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [10] 0 0
Documentation of LVEF
Timepoint [10] 0 0
throughout study duration, average of 3.5 years; annual evaluations
Primary outcome [11] 0 0
Documentation of LVESV
Timepoint [11] 0 0
throughout study duration, average of 3.5 years; annual evaluations

Eligibility
Key inclusion criteria
* Planned de novo 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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Standard contraindication for CRT
* Already or previously implanted with CRT system
* • 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
14/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Canberra Heart Rhythm Foundation - Canberra
Recruitment hospital [2] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [3] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 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
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Bonheiden
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Czechia
State/province [7] 0 0
Olomouc
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha
Country [9] 0 0
Czechia
State/province [9] 0 0
Ceské Budejovice
Country [10] 0 0
France
State/province [10] 0 0
Brest
Country [11] 0 0
France
State/province [11] 0 0
Caen
Country [12] 0 0
France
State/province [12] 0 0
Chartres
Country [13] 0 0
France
State/province [13] 0 0
Limoges
Country [14] 0 0
France
State/province [14] 0 0
Lomme
Country [15] 0 0
France
State/province [15] 0 0
Lorient
Country [16] 0 0
France
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Lyon
Country [17] 0 0
France
State/province [17] 0 0
Marseille
Country [18] 0 0
France
State/province [18] 0 0
Massy
Country [19] 0 0
France
State/province [19] 0 0
Melun
Country [20] 0 0
France
State/province [20] 0 0
Montpellier
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France
State/province [21] 0 0
Nantes
Country [22] 0 0
France
State/province [22] 0 0
Paris
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France
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Pessac Cedex
Country [24] 0 0
France
State/province [24] 0 0
Périgueux
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France
State/province [25] 0 0
Saint-Lô
Country [26] 0 0
France
State/province [26] 0 0
Saint-Étienne
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France
State/province [27] 0 0
Strasbourg
Country [28] 0 0
France
State/province [28] 0 0
Toulouse
Country [29] 0 0
France
State/province [29] 0 0
Tours
Country [30] 0 0
France
State/province [30] 0 0
Valence
Country [31] 0 0
France
State/province [31] 0 0
Vannes
Country [32] 0 0
Germany
State/province [32] 0 0
Sachsen
Country [33] 0 0
Germany
State/province [33] 0 0
Bad Berka
Country [34] 0 0
Germany
State/province [34] 0 0
Bad Oeynhausen
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Brandenburg
Country [37] 0 0
Germany
State/province [37] 0 0
Buchholz
Country [38] 0 0
Germany
State/province [38] 0 0
Erlangen
Country [39] 0 0
Germany
State/province [39] 0 0
Gießen
Country [40] 0 0
Germany
State/province [40] 0 0
Güstrow
Country [41] 0 0
Germany
State/province [41] 0 0
Jena
Country [42] 0 0
Germany
State/province [42] 0 0
Lingen
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Germany
State/province [43] 0 0
Lübeck
Country [44] 0 0
Germany
State/province [44] 0 0
Merseburg
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Germany
State/province [45] 0 0
Minden
Country [46] 0 0
Germany
State/province [46] 0 0
München
Country [47] 0 0
Germany
State/province [47] 0 0
Münster
Country [48] 0 0
Germany
State/province [48] 0 0
Neuss
Country [49] 0 0
Germany
State/province [49] 0 0
Oldenburg
Country [50] 0 0
Germany
State/province [50] 0 0
Rothenfelde
Country [51] 0 0
Germany
State/province [51] 0 0
Würzburg
Country [52] 0 0
Hungary
State/province [52] 0 0
Balatonfüred
Country [53] 0 0
Hungary
State/province [53] 0 0
Budapest
Country [54] 0 0
Hungary
State/province [54] 0 0
Pécs
Country [55] 0 0
Israel
State/province [55] 0 0
Ashdod
Country [56] 0 0
Israel
State/province [56] 0 0
Be'er Sheva
Country [57] 0 0
Israel
State/province [57] 0 0
H_olon
Country [58] 0 0
Israel
State/province [58] 0 0
Jerusalem
Country [59] 0 0
Israel
State/province [59] 0 0
Kfar Saba
Country [60] 0 0
Israel
State/province [60] 0 0
Petach Tikva
Country [61] 0 0
Israel
State/province [61] 0 0
Re?ovot
Country [62] 0 0
Israel
State/province [62] 0 0
Tel HaShomer
Country [63] 0 0
Israel
State/province [63] 0 0
Zerifin
Country [64] 0 0
Italy
State/province [64] 0 0
Mailand
Country [65] 0 0
Italy
State/province [65] 0 0
Roma
Country [66] 0 0
Japan
State/province [66] 0 0
Fukuoka
Country [67] 0 0
Japan
State/province [67] 0 0
Hiroshima
Country [68] 0 0
Japan
State/province [68] 0 0
Kanagawa
Country [69] 0 0
Japan
State/province [69] 0 0
Sagamihara
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Japan
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Saitama
Country [71] 0 0
Japan
State/province [71] 0 0
Tokio
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Japan
State/province [72] 0 0
Toyoake
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Japan
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Yokohama
Country [74] 0 0
Latvia
State/province [74] 0 0
Riga
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Poland
State/province [75] 0 0
Poznan
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Poland
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Warsaw
Country [77] 0 0
Poland
State/province [77] 0 0
Lódz
Country [78] 0 0
Portugal
State/province [78] 0 0
Carnaxide
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Portugal
State/province [79] 0 0
Lisboa
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Portugal
State/province [80] 0 0
Porto
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Portugal
State/province [81] 0 0
Évora
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Singapore
State/province [82] 0 0
Singapore
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Slovakia
State/province [83] 0 0
Banská Bystrica
Country [84] 0 0
Slovakia
State/province [84] 0 0
Bratislava
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Slovakia
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Košice
Country [86] 0 0
South Africa
State/province [86] 0 0
Cape Town
Country [87] 0 0
South Africa
State/province [87] 0 0
Pietermaritzburg
Country [88] 0 0
South Africa
State/province [88] 0 0
Pretoria
Country [89] 0 0
South Africa
State/province [89] 0 0
Umhlanga
Country [90] 0 0
South Africa
State/province [90] 0 0
Westville
Country [91] 0 0
Spain
State/province [91] 0 0
Alicante
Country [92] 0 0
Spain
State/province [92] 0 0
Barcelona
Country [93] 0 0
Spain
State/province [93] 0 0
Burgos
Country [94] 0 0
Spain
State/province [94] 0 0
Donostia
Country [95] 0 0
Spain
State/province [95] 0 0
Madrid
Country [96] 0 0
Spain
State/province [96] 0 0
Málaga
Country [97] 0 0
Spain
State/province [97] 0 0
Valencia
Country [98] 0 0
Spain
State/province [98] 0 0
Vigo
Country [99] 0 0
Switzerland
State/province [99] 0 0
Zürich
Country [100] 0 0
Taiwan
State/province [100] 0 0
Kaohsiung City
Country [101] 0 0
Taiwan
State/province [101] 0 0
New Taipei City
Country [102] 0 0
Taiwan
State/province [102] 0 0
Yilan City
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Chertsey
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Dudley
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Kettering
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Truro

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Maria Jung, Dr.
Address 0 0
Country 0 0
Phone 0 0
+493068905
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data in planned to be shared with other researchers


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03366545