Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
BIO|STREAM HF
1 other identifier
observational
3,030
19 countries
107
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Longer than P75 for all trials
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
May 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedFebruary 12, 2026
February 1, 2026
7.4 years
November 27, 2017
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Number of cardiovascular adverse events
Number of unplanned hospitalization for cardiovascular cause
throughout study duration, average of 3.5 years; annual evaluations
Number of patient deaths
Number of all-cause mortality
throughout study duration, average of 3.5 years; annual evaluations
Number of all cause hospitalization
Number of all cause hospitalization
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
throughout study duration, average of 3.5 years; annual evaluations
Number of patients with cerebrovascular events
Number of cerebrovascular events requiring hospitalization
throughout study duration, average of 3.5 years; annual evaluations
Number of all adverse device effects
Number of all adverse device effects
throughout study duration, average of 3.5 years; annual evaluations
Number of all device deficiencies
Number of all device deficiencies
throughout study duration, average of 3.5 years; annual evaluations
Assessment of patients benefit from CRT
Documentation of NYHA classification \[I-IV\]
throughout study duration, average of 3.5 years; annual evaluations
Number of patient deaths with cardiovascular cause
Number of patient deaths with cardiovascular cause
throughout study duration, average of 3.5 years; annual evaluations
Documentation of LVEF
Left ventricular ejection fraction \[%\]
throughout study duration, average of 3.5 years; annual evaluations
Documentation of LVESV
Left ventricular end-systolic volume \[ml\]
throughout study duration, average of 3.5 years; annual evaluations
Interventions
Observation and documentation of routine care for CRT patients
Eligibility Criteria
Representative population of CRTpatients at clinical sites
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (114)
Canberra Heart Rhythm Foundation
Canberra, Australia
The Canberra Hospital
Canberra, Australia
Lyell McEwin Hospital
Elizabeth Vale, Australia
Liverpool Hospital
Liverpool, Australia
Sydney Adventist Hospital
Sydney, Australia
Westmead Hospital
Westmead, 2145, Australia
Westmead Private Hosptial
Westmead, Australia
Kepler Universitätsklinikum
Linz, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
Medizinische Universität Wien
Vienna, Austria
Imelda Ziekenhuis
Bonheiden, 2820, Belgium
UZ Brussel
Brussels, 1090, Belgium
CHR de la Citadelle - Liège
Liège, Belgium
Nemocnice České Budějovice
České Budějovice, Czechia
Fakultní nemocnice Olomouc
Olomouc, 77900, Czechia
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
CHU de Brest
Brest, France
Le Centre Hospitalier Universitaire de CAEN
Caen, France
Centre Hospitalier Louis Pasteur
Chartres, France
CH Saint Philibert
Lomme, France
Centre Hospitalier Lorient
Lorient, France
Hôpital privé Clairval
Marseille, 13009, France
Hopital de la Timone (CHU La Timone)
Marseille, France
Hôpital Privé / Institute Jaques Cartier
Massy, France
Clinique les Fontaines
Melun, France
CHU Montpellier
Montpellier, France
Clinique du Millenaire
Montpellier, France
Hôpital privé du Confluent
Nantes, France
Hopital Pitie-Salpetriere
Paris, France
Hôpital Haut Lévêque
Pessac, France
Centre Hospitalier de Périgeux
Périgueux, France
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne, France
Centre Hospitalier Mémorial de Saint-Lô
Saint-Lô, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Centre Hospitalier de Rangueil
Toulouse, France
Clinique Pasteur Toulouse
Toulouse, France
Chru de Tours
Tours, France
CH de Valence
Valence, France
Centre Hospitalier Bretagne Atlantique Prosper Chubert
Vannes, France
Städtisches Klinikum St.Georg
Leipzig, Saxony, 04129, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
HDZ Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Maria Heimsuchung - Carita-Klinik Pankow
Berlin, 13187, Germany
Städtisches Klinikum Brandenburg GmbH
Brandenburg, Germany
Krankenhaus Buchholz und Winsen AöR
Buchholz, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Universitätsklinikum Giessen und Marburg
Giessen, 35392, Germany
KMG Klinikum Güstrow
Güstrow, Germany
Klinikum der Universität Jena
Jena, 07743, Germany
Bonifatius Hospital Lingen gGmbH
Lingen, Germany
Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
Lübeck, Germany
Carl-von-Basedow-Klinikum Saalekreis GmbH
Merseburg, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
Klinikum der LMU / Campus Großhadern
München, 81377, Germany
Universitätsklinikum Münster
Münster, Germany
Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
Neuss, Germany
Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde
Rothenfelde, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
State Hospital of Cardiology
Balatonfüred, Hungary
Gottsegen György Országos Kardiológiai Intézet
Budapest, Hungary
Semmelweis Medical University
Budapest, Hungary
The University of Pécs
Pécs, Hungary
Assuta Medical Center
Ashdod, Israel
Ben-Gurion University of the Negev
Beersheba, 84101, Israel
Wolfson Medical Center
Holon, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Kaplan Medical Center
Rehovot, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Shamir Medical Center
Ẕerifin, 70300, Israel
Ospedale San Raffaele
Milan, Italy
Policlinico Casilino
Roma, Italy
Kokura Memorial Hospital
Fukuoka, Japan
Hiroshima Prefectural Hospital
Hiroshima, Japan
Tokai University Hospital
Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Japan
Saitama Medical University International Medical Center
Saitama, Japan
Juntendo University Hospital
Tokyo, Japan
Fujita Health University Hospital
Toyoake, Japan
Pauls Stradins Clinical University Hospital
Riga, Latvia
Medical University of Lodz
Lodz, Poland
Szpital Kliniczny Przemienienia Pańskiego
Poznan, Poland
The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute
Warsaw, Poland
Hospital de Santa Cruz
Carnaxide, Portugal
Hospital Espirito Santo de Evora
Evora, Portugal
Hospital de Santa Maria
Lisbon, Portugal
Hospital de Santo António
Porto, Portugal
Changi General Hospital
Singapore, Singapore
SÚSCCH
Banská Bystrica, Slovakia
NÚSCH Bratislava a.s.
Bratislava, Slovakia
East-Slovak Cardiology Institute (VUSCH)
Košice, Slovakia
Mediclinic Panorama Hospital
Cape Town, South Africa
Mediclinic Pietermaritzburg
Pietermaritzburg, South Africa
Mediclinic Midstream
Pretoria, South Africa
Unitas Hospital
Pretoria, South Africa
Gateway Private Hospital
Umhlanga, South Africa
Life Westville
Westville, South Africa
Hospital General Universitario de Alicante
Alicante, Spain
Centro Médico Teknon
Barcelona, 08022, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitario La Fé
Valencia, Spain
Hospital Álvaro Cunqueiro
Vigo, Spain
Universitätsspital Zürich
Zurich, Switzerland
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
St. Peter's Hospital
Chertsey, United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
Kettering General Hospital
Kettering, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2017
First Posted
December 8, 2017
Study Start
May 14, 2018
Primary Completion
September 22, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
No individual participant data in planned to be shared with other researchers