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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
Date last updated
25/11/2024

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
1/03/2026
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
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Belgium
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Bonheiden
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Belgium
State/province [5] 0 0
Brussels
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Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Czechia
State/province [7] 0 0
Olomouc
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Czechia
State/province [8] 0 0
Praha
Country [9] 0 0
Czechia
State/province [9] 0 0
Ceské Budejovice
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France
State/province [10] 0 0
Brest
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France
State/province [11] 0 0
Caen
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France
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Chartres
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France
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Limoges
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France
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Lomme
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France
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Lorient
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France
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Lyon
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France
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Marseille
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France
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Massy
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France
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Melun
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France
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Montpellier
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Nantes
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Paris
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Pessac Cedex
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Périgueux
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Saint-Lô
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Saint-Étienne
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Strasbourg
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Toulouse
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Tours
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Valence
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France
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Vannes
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Germany
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Sachsen
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Germany
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Bad Berka
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Germany
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Bad Oeynhausen
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Germany
State/province [35] 0 0
Berlin
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Germany
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Brandenburg
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Germany
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Buchholz
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Erlangen
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Gießen
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Güstrow
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Jena
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Lingen
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Lübeck
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Merseburg
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Minden
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München
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Münster
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Neuss
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Oldenburg
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Germany
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Rothenfelde
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Würzburg
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Hungary
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Balatonfüred
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Budapest
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Pécs
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Ashdod
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Be'er Sheva
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H_olon
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Jerusalem
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Kfar Saba
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Petach Tikva
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Re?ovot
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Tel HaShomer
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Zerifin
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Mailand
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Roma
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Fukuoka
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Hiroshima
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Kanagawa
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Sagamihara
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Saitama
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Tokio
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Toyoake
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Yokohama
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Riga
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Poznan
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Warsaw
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Lódz
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Portugal
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Carnaxide
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Évora
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Singapore
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Singapore
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Slovakia
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Banská Bystrica
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Slovakia
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Bratislava
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Slovakia
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Košice
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South Africa
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Cape Town
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South Africa
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Pietermaritzburg
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South Africa
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Pretoria
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South Africa
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Umhlanga
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South Africa
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Westville
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Spain
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Alicante
Country [92] 0 0
Spain
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Barcelona
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Spain
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Burgos
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Spain
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Donostia
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Spain
State/province [95] 0 0
Madrid
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Spain
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Málaga
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Spain
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Valencia
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Spain
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Vigo
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Switzerland
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Zürich
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Taiwan
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Kaohsiung City
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Taiwan
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New Taipei City
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Taiwan
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Yilan City
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United Kingdom
State/province [103] 0 0
Chertsey
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United Kingdom
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Dudley
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United Kingdom
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Kettering
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United Kingdom
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Truro

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/study/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
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03366545