Heart FailureBIO|STREAM HFNCT03366545
Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 114 sites in 20 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy (CRT)
- Type of treatment
- Medical device
- How many people
- 3,030 participants
- Where
- 114 sitesin 20 countries
- Study dates
- 14 May 2018to 30 Jun 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Representative population of CRTpatients at clinical sites
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
114 sites in 20 countries.
114 sites in 20 countries
France23 sites
CHU de Brest
Brest
Le Centre Hospitalier Universitaire de CAEN
Caen
Centre Hospitalier Louis Pasteur
Chartres
CH Saint Philibert
Lomme
Centre Hospitalier Lorient
Lorient
Hôpital privé Clairval
Marseille, 13009
Hopital de la Timone (CHU La Timone)
Marseille
Hôpital Privé / Institute Jaques Cartier
Massy
Clinique les Fontaines
Melun
CHU Montpellier
Montpellier
Clinique du Millenaire
Montpellier
Hôpital privé du Confluent
Nantes
Hopital Pitie-Salpetriere
Paris
Centre Hospitalier de Périgeux
Périgueux
Hôpital Haut Lévêque
Pessac
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne
Centre Hospitalier Mémorial de Saint-Lô
Saint-Lô
Hôpitaux Universitaires de Strasbourg
Strasbourg
Centre Hospitalier de Rangueil
Toulouse
Clinique Pasteur Toulouse
Toulouse
Chru de Tours
Tours
CH de Valence
Valence
Centre Hospitalier Bretagne Atlantique Prosper Chubert
Vannes
Germany19 sites
Zentralklinik Bad Berka GmbH
Bad Berka
HDZ Bad Oeynhausen
Bad Oeynhausen, 32545
Maria Heimsuchung - Carita-Klinik Pankow
Berlin, 13187
Städtisches Klinikum Brandenburg GmbH
Brandenburg
Krankenhaus Buchholz und Winsen AöR
Buchholz
Universitätsklinikum Erlangen
Erlangen
Universitätsklinikum Giessen und Marburg
Giessen, 35392
KMG Klinikum Güstrow
Güstrow
Klinikum der Universität Jena
Jena, 07743
Städtisches Klinikum St.Georg
Leipzig, Saxony, 04129
Bonifatius Hospital Lingen gGmbH
Lingen
Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
Lübeck
Carl-von-Basedow-Klinikum Saalekreis GmbH
Merseburg
Johannes Wesling Klinikum Minden
Minden
Klinikum der LMU / Campus Großhadern
München, 81377
Universitätsklinikum Münster
Münster
Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
Neuss
Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde
Rothenfelde
Universitätsklinikum Würzburg
Würzburg
Spain10 sites
Hospital General Universitario de Alicante
Alicante
Centro Médico Teknon
Barcelona, 08022
Hospital Universitario de Bellvitge
Barcelona
Hospital Universitario de Burgos
Burgos
Hospital Universitario Donostia
Donostia / San Sebastian
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Hospital General Universitario de Valencia
Valencia
Hospital Universitario La Fé
Valencia
Hospital Álvaro Cunqueiro
Vigo
Israel9 sites
Assuta Medical Center
Ashdod
Ben-Gurion University of the Negev
Beersheba, 84101
Wolfson Medical Center
Holon
Shaare Zedek Medical Center
Jerusalem
Meir Medical Center
Kfar Saba
Rabin Medical Center
Petah Tikva, 49100
Kaplan Medical Center
Rehovot
Chaim Sheba Medical Center
Tel HaShomer, 52621
Shamir Medical Center
Tsrifin, 70300
Australia7 sites
Canberra Heart Rhythm Foundation
Canberra
The Canberra Hospital
Canberra
Lyell McEwin Hospital
Elizabeth Vale
Liverpool Hospital
Liverpool
Sydney Adventist Hospital
Sydney
Westmead Hospital
Westmead, 2145
Westmead Private Hosptial
Westmead
Japan7 sites
Kokura Memorial Hospital
Fukuoka
Hiroshima Prefectural Hospital
Hiroshima
Tokai University Hospital
Kanagawa
Kitasato University Hospital
Sagamihara
Saitama Medical University International Medical Center
Saitama
Juntendo University Hospital
Tokyo
Fujita Health University Hospital
Toyoake
South Africa6 sites
Mediclinic Panorama Hospital
Cape Town
Mediclinic Pietermaritzburg
Pietermaritzburg
Mediclinic Midstream
Pretoria
Unitas Hospital
Pretoria
Gateway Private Hospital
Umhlanga
Life Westville
Westville
Hungary4 sites
State Hospital of Cardiology
Balatonfüred
Gottsegen György Országos Kardiológiai Intézet
Budapest
Semmelweis Medical University
Budapest
The University of Pécs
Pécs
Portugal4 sites
Hospital de Santa Cruz
Carnaxide
Hospital Espirito Santo de Evora
Evora
Hospital de Santa Maria
Lisbon
Hospital de Santo António
Porto
Austria3 sites
Kepler Universitätsklinikum
Linz
Universitätsklinikum St. Pölten
Sankt Pölten
Medizinische Universität Wien
Vienna
Belgium3 sites
Imelda Ziekenhuis
Bonheiden, 2820
UZ Brussel
Brussels, 1090
CHR de la Citadelle - Liège
Liège
Czechia3 sites
Nemocnice České Budějovice
České Budějovice
Fakultní nemocnice Olomouc
Olomouc, 77900
Institute for Clinical and Experimental Medicine (IKEM)
Prague
Poland3 sites
Medical University of Lodz
Lodz
Szpital Kliniczny Przemienienia Pańskiego
Poznan
The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute
Warsaw
Slovakia3 sites
SÚSCCH
Banská Bystrica
NÚSCH Bratislava a.s.
Bratislava
East-Slovak Cardiology Institute (VUSCH)
Košice
United Kingdom3 sites
St. Peter's Hospital
Chertsey
Russells Hall Hospital
Dudley
Kettering General Hospital
Kettering
Taiwan2 sites
Kaohsiung Veterans General Hospital
Kaohsiung City
Far Eastern Memorial Hospital
New Taipei City
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy (CRT)
- Keywords
- cardiac resynchronization therapy, CRT, clinical routine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy (CRT)Device
Observation and documentation of routine care for CRT patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cardiovascular adverse events
Number of unplanned hospitalization for cardiovascular cause
Measured: throughout study duration, average of 3.5 years; annual evaluations
Number of patient deaths
Number of all-cause mortality
Measured: throughout study duration, average of 3.5 years; annual evaluations
Number of all cause hospitalization
Number of all cause hospitalization
Measured: throughout study duration, average of 3.5 years; annual evaluations
Number of patients with worsening of heart failure events
Number of unplanned hospitalization for worsening of heart failure
Measured: throughout study duration, average of 3.5 years; annual evaluations
Number of patients with cerebrovascular events
Number of cerebrovascular events requiring hospitalization
Measured: throughout study duration, average of 3.5 years; annual evaluations
Number of all adverse device effects
Number of all adverse device effects
Measured: throughout study duration, average of 3.5 years; annual evaluations
Number of all device deficiencies
Number of all device deficiencies
Measured: throughout study duration, average of 3.5 years; annual evaluations
Assessment of patients benefit from CRT
Documentation of NYHA classification [I-IV]
Measured: throughout study duration, average of 3.5 years; annual evaluations
Number of patient deaths with cardiovascular cause
Number of patient deaths with cardiovascular cause
Measured: throughout study duration, average of 3.5 years; annual evaluations
Documentation of LVEF
Left ventricular ejection fraction [%]
Measured: throughout study duration, average of 3.5 years; annual evaluations
Documentation of LVESV
Left ventricular end-systolic volume [ml]
Measured: throughout study duration, average of 3.5 years; annual evaluations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start14 May 2018
- Primary completion22 Sep 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,030 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366545
- Sponsor's protocol ID
- CR021
- Acronym
- BIO|STREAM HF
- Status last verified
- Feb 2026
- First submitted
- 27 Nov 2017
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data in planned to be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
- ClinicalTrials.gov ID
- NCT03366545
- Acronym / sponsor ID
- BIO|STREAM HF / CR021
- Conditions
- Heart Failure
- Keywords
- cardiac resynchronization therapy, CRT, clinical routine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,030 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 14 May 2018 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Representative population of CRTpatients at clinical sites
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Resynchronization Therapy (CRT)Observation and documentation of routine care for CRT patients | Device | – |
Primary outcome
Number of cardiovascular adverse events
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Number of unplanned hospitalization for cardiovascular cause
Number of patient deaths
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all-cause mortality
Number of all cause hospitalization
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all cause hospitalization
Number of patients with worsening of heart failure events
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Number of unplanned hospitalization for worsening of heart failure
Number of patients with cerebrovascular events
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Number of cerebrovascular events requiring hospitalization
Number of all adverse device effects
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all adverse device effects
Number of all device deficiencies
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all device deficiencies
Assessment of patients benefit from CRT
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Documentation of NYHA classification [I-IV]
Number of patient deaths with cardiovascular cause
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Number of patient deaths with cardiovascular cause
Documentation of LVEF
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Left ventricular ejection fraction [%]
Documentation of LVESV
Time frame: throughout study duration, average of 3.5 years; annual evaluations
Left ventricular end-systolic volume [ml]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. No individual participant data in planned to be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
114 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 114 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 114 sites in France, Germany, Spain, Israel, Australia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cardiovascular adverse events (time frame: throughout study duration, average of 3.5 years; annual evaluations). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.