Heart failure device study aims to improve patient care
NCT ID NCT03366545
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows over 3,000 heart failure patients who have a BIOTRONIC CRT device implanted. Researchers will track hospitalizations, deaths, and device issues over time to understand how well the devices work in real life. The goal is to find ways to improve treatment and device settings for future patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cardiac Resynchronization Therapy (CRT) device
- What this could lead to
- If successful, this could help doctors better predict heart failure events and improve CRT device settings for future patients.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly benefit participants. Results may not lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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3,030 people
The number who actually took part.
- Started
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May 2018
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Representative population of CRTpatients at clinical sites
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Assuta Medical Center
Ashdod, Israel
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Ben-Gurion University of the Negev
Beersheba, 84101, Israel
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Bonifatius Hospital Lingen gGmbH
Lingen, Germany
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CH Saint Philibert
Lomme, France
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CH de Valence
Valence, France
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CHR de la Citadelle - Liège
Liège, Belgium
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CHU Montpellier
Montpellier, France
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CHU de Brest
Brest, France
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Canberra Heart Rhythm Foundation
Canberra, Australia
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Carl-von-Basedow-Klinikum Saalekreis GmbH
Merseburg, Germany
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Centre Hospitalier Bretagne Atlantique Prosper Chubert
Vannes, France
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Centre Hospitalier Lorient
Lorient, France
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Centre Hospitalier Louis Pasteur
Chartres, France
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Centre Hospitalier Mémorial de Saint-Lô
Saint-Lô, France
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Centre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne, France
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Centre Hospitalier de Périgeux
Périgueux, France
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Centre Hospitalier de Rangueil
Toulouse, France
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Centro Médico Teknon
Barcelona, 08022, Spain
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Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
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Changi General Hospital
Singapore, Singapore
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Chru de Tours
Tours, France
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Clinique Pasteur Toulouse
Toulouse, France
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Clinique du Millenaire
Montpellier, France
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Clinique les Fontaines
Melun, France
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East-Slovak Cardiology Institute (VUSCH)
Košice, Slovakia
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Fakultní nemocnice Olomouc
Olomouc, 77900, Czechia
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Far Eastern Memorial Hospital
New Taipei City, Taiwan
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Fujita Health University Hospital
Toyoake, Japan
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Gateway Private Hospital
Umhlanga, South Africa
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Gottsegen György Országos Kardiológiai Intézet
Budapest, Hungary
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HDZ Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
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Hiroshima Prefectural Hospital
Hiroshima, Japan
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Hopital Pitie-Salpetriere
Paris, France
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Hopital de la Timone (CHU La Timone)
Marseille, France
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Hospital Espirito Santo de Evora
Evora, Portugal
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Hospital General Universitario de Alicante
Alicante, Spain
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Hospital General Universitario de Valencia
Valencia, Spain
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Hospital Universitario 12 de Octubre
Madrid, Spain
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Hospital Universitario Donostia
Donostia / San Sebastian, Spain
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Hospital Universitario La Fé
Valencia, Spain
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Hospital Universitario Virgen de la Victoria
Málaga, Spain
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Hospital Universitario de Bellvitge
Barcelona, Spain
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Hospital Universitario de Burgos
Burgos, Spain
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Hospital de Santa Cruz
Carnaxide, Portugal
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Hospital de Santa Maria
Lisbon, Portugal
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Hospital de Santo António
Porto, Portugal
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Hospital Álvaro Cunqueiro
Vigo, Spain
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Hôpital Haut Lévêque
Pessac, France
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Hôpital Privé / Institute Jaques Cartier
Massy, France
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Hôpital privé Clairval
Marseille, 13009, France
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Hôpital privé du Confluent
Nantes, France
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Hôpitaux Universitaires de Strasbourg
Strasbourg, France
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Imelda Ziekenhuis
Bonheiden, 2820, Belgium
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Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
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Johannes Wesling Klinikum Minden
Minden, Germany
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Juntendo University Hospital
Tokyo, Japan
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KMG Klinikum Güstrow
Güstrow, Germany
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Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
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Kaplan Medical Center
Rehovot, Israel
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Kepler Universitätsklinikum
Linz, Austria
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Kettering General Hospital
Kettering, United Kingdom
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Kitasato University Hospital
Sagamihara, Japan
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Klinikum der LMU / Campus Großhadern
München, 81377, Germany
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Klinikum der Universität Jena
Jena, 07743, Germany
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Kokura Memorial Hospital
Fukuoka, Japan
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Krankenhaus Buchholz und Winsen AöR
Buchholz, Germany
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Le Centre Hospitalier Universitaire de CAEN
Caen, France
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Life Westville
Westville, South Africa
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Liverpool Hospital
Liverpool, Australia
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Lyell McEwin Hospital
Elizabeth Vale, Australia
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Maria Heimsuchung - Carita-Klinik Pankow
Berlin, 13187, Germany
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Medical University of Lodz
Lodz, Poland
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Mediclinic Midstream
Pretoria, South Africa
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Mediclinic Panorama Hospital
Cape Town, South Africa
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Mediclinic Pietermaritzburg
Pietermaritzburg, South Africa
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Medizinische Universität Wien
Vienna, Austria
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Meir Medical Center
Kfar Saba, Israel
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Nemocnice České Budějovice
České Budějovice, Czechia
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NÚSCH Bratislava a.s.
Bratislava, Slovakia
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Ospedale San Raffaele
Milan, Italy
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Pauls Stradins Clinical University Hospital
Riga, Latvia
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Policlinico Casilino
Roma, Italy
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Rabin Medical Center
Petah Tikva, 49100, Israel
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Russells Hall Hospital
Dudley, United Kingdom
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Saitama Medical University International Medical Center
Saitama, Japan
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Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde
Rothenfelde, Germany
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Semmelweis Medical University
Budapest, Hungary
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Shaare Zedek Medical Center
Jerusalem, Israel
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Shamir Medical Center
Ẕerifin, 70300, Israel
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St. Peter's Hospital
Chertsey, United Kingdom
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State Hospital of Cardiology
Balatonfüred, Hungary
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Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
Neuss, Germany
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Städtisches Klinikum Brandenburg GmbH
Brandenburg, Germany
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Städtisches Klinikum St.Georg
Leipzig, Saxony, 04129, Germany
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Sydney Adventist Hospital
Sydney, Australia
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Szpital Kliniczny Przemienienia Pańskiego
Poznan, Poland
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SÚSCCH
Banská Bystrica, Slovakia
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The Canberra Hospital
Canberra, Australia
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The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute
Warsaw, Poland
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The University of Pécs
Pécs, Hungary
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Tokai University Hospital
Kanagawa, Japan
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UZ Brussel
Brussels, 1090, Belgium
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Unitas Hospital
Pretoria, South Africa
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Universitätsklinikum Erlangen
Erlangen, Germany
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Universitätsklinikum Giessen und Marburg
Giessen, 35392, Germany
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Universitätsklinikum Münster
Münster, Germany
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Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
Lübeck, Germany
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Universitätsklinikum St. Pölten
Sankt Pölten, Austria
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Universitätsklinikum Würzburg
Würzburg, Germany
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Universitätsspital Zürich
Zurich, Switzerland
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Westmead Hospital
Westmead, 2145, Australia
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Westmead Private Hosptial
Westmead, Australia
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Wolfson Medical Center
Holon, Israel
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Zentralklinik Bad Berka GmbH
Bad Berka, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily mindful breathing ease heart failure symptoms?
- Can a smartphone app keep heart failure patients out of the hospital?
- Can better training get doctors to talk about what matters most to dying veterans?
- Can AI read heart ultrasounds as well as trained sonographers?
- Can modern heart failure drugs reverse damage in three months?