Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices (BIO|STREAM HF)

February 10, 2026 updated by: Biotronik SE & Co. KG
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3030

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Canberra, Australia
        • The Canberra Hospital
      • Canberra, Australia
        • Canberra Heart Rhythm Foundation
      • Elizabeth Vale, Australia
        • Lyell McEwin Hospital
      • Liverpool, Australia
        • Liverpool Hospital
      • Sydney, Australia
        • Sydney Adventist Hospital
      • Westmead, Australia, 2145
        • Westmead Hospital
      • Westmead, Australia
        • Westmead Private Hosptial
  • Austria
      • Linz, Austria
        • Kepler Universitätsklinikum
      • Sankt Pölten, Austria
        • Universitätsklinikum St. Pölten
      • Vienna, Austria
        • Medizinische Universität Wien
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis
      • Brussels, Belgium, 1090
        • Uz Brussel
      • Liège, Belgium
        • CHR de la Citadelle - Liège
  • Czechia
      • Olomouc, Czechia, 77900
        • Fakultni nemocnice Olomouc
      • Prague, Czechia
        • Institute for Clinical and Experimental Medicine (IKEM)
      • České Budějovice, Czechia
        • Nemocnice Ceske Budejovice
  • France
      • Brest, France
        • CHU de Brest
      • Caen, France
        • Le Centre Hospitalier Universitaire de CAEN
      • Chartres, France
        • Centre Hospitalier Louis Pasteur
      • Lomme, France
        • CH Saint Philibert
      • Lorient, France
        • Centre Hospitalier Lorient
      • Marseille, France, 13009
        • Hopital Prive Clairval
      • Marseille, France
        • Hopital de la Timone (CHU La Timone)
      • Massy, France
        • Hôpital Privé / Institute Jaques Cartier
      • Melun, France
        • Clinique les Fontaines
      • Montpellier, France
        • CHU Montpellier
      • Montpellier, France
        • Clinique du Millénaire
      • Nantes, France
        • Hôpital Privé du Confluent
      • Paris, France
        • Hôpital Pitié-Salpétrière
      • Pessac, France
        • Hopital Haut Leveque
      • Périgueux, France
        • Centre Hospitalier de Périgeux
      • Saint-Etienne, France
        • Centre Hospitalier Universitaire de Saint-Etienne
      • Saint-Lô, France
        • Centre Hospitalier Mémorial de Saint-Lô
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg
      • Toulouse, France
        • Clinique Pasteur Toulouse
      • Toulouse, France
        • Centre Hospitalier de Rangueil
      • Tours, France
        • Chru De Tours
      • Valence, France
        • CH de Valence
      • Vannes, France
        • Centre Hospitalier Bretagne Atlantique Prosper Chubert
  • Germany
      • Bad Berka, Germany
        • Zentralklinik Bad Berka GmbH
      • Bad Oeynhausen, Germany, 32545
        • HDZ Bad Oeynhausen
      • Berlin, Germany, 13187
        • Maria Heimsuchung - Carita-Klinik Pankow
      • Brandenburg, Germany
        • Städtisches Klinikum Brandenburg GmbH
      • Buchholz, Germany
        • Krankenhaus Buchholz und Winsen AöR
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Giessen, Germany, 35392
        • Universitätsklinikum Gießen und Marburg
      • Güstrow, Germany
        • KMG Klinikum Güstrow
      • Jena, Germany, 07743
        • Klinikum der Universität Jena
      • Lingen, Germany
        • Bonifatius Hospital Lingen gGmbH
      • Lübeck, Germany
        • Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
      • Merseburg, Germany
        • Carl-von-Basedow-Klinikum Saalekreis GmbH
      • Minden, Germany
        • Johannes Wesling Klinikum Minden
      • München, Germany, 81377
        • Klinikum der LMU / Campus Großhadern
      • Münster, Germany
        • Universitätsklinikum Münster
      • Neuss, Germany
        • Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
      • Rothenfelde, Germany
        • Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde
      • Würzburg, Germany
        • Universitätsklinikum Würzburg
    • Saxony
      • Leipzig, Saxony, Germany, 04129
        • Städtisches Klinikum St.Georg
  • Hungary
      • Balatonfüred, Hungary
        • State Hospital of Cardiology
      • Budapest, Hungary
        • Semmelweis Medical University
      • Budapest, Hungary
        • Gottsegen György Országos Kardiológiai Intézet
      • Pécs, Hungary
        • The University of Pécs
  • Israel
      • Ashdod, Israel
        • Assuta Medical Center
      • Beersheba, Israel, 84101
        • Ben-Gurion University of the Negev
      • Holon, Israel
        • Wolfson Medical Center
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Kfar Saba, Israel
        • Meir Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Rehovot, Israel
        • Kaplan Medical Center
      • Tel Litwinsky, Israel, 52621
        • Chaim Sheba Medical Center
      • Ẕerifin, Israel, 70300
        • Shamir Medical Center
  • Italy
      • Milan, Italy
        • Ospedale San Raffaele
      • Roma, Italy
        • Policlinico Casilino
  • Japan
      • Fukuoka, Japan
        • Kokura Memorial Hospital
      • Hiroshima, Japan
        • Hiroshima Prefectural Hospital
      • Kanagawa, Japan
        • Tokai University Hospital
      • Sagamihara, Japan
        • Kitasato University Hospital
      • Saitama, Japan
        • Saitama Medical University International Medical Center
      • Tokyo, Japan
        • Juntendo University Hospital
      • Toyoake, Japan
        • Fujita Health University Hospital
  • Latvia
      • Riga, Latvia
        • Pauls Stradinš Clinical University Hospital
  • Poland
      • Lodz, Poland
        • Medical University of Lodz
      • Poznan, Poland
        • Szpital Kliniczny Przemienienia Pańskiego
      • Warsaw, Poland
        • The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute
  • Portugal
      • Carnaxide, Portugal
        • Hospital de Santa Cruz
      • Evora, Portugal
        • Hospital Espirito Santo de Evora
      • Lisbon, Portugal
        • Hospital de Santa Maria
      • Porto, Portugal
        • Hospital de Santo Antonio
  • Singapore
      • Singapore, Singapore
        • Changi General Hospital
  • Slovakia
      • Banská Bystrica, Slovakia
        • SUSCCH
      • Bratislava, Slovakia
        • NÚSCH Bratislava a.s.
      • Košice, Slovakia
        • East-Slovak Cardiology Institute (VUSCH)
  • South Africa
      • Cape Town, South Africa
        • Mediclinic Panorama Hospital
      • Pietermaritzburg, South Africa
        • Mediclinic Pietermaritzburg
      • Pretoria, South Africa
        • Unitas Hospital
      • Pretoria, South Africa
        • Mediclinic Midstream
      • Umhlanga, South Africa
        • Gateway Private Hospital
      • Westville, South Africa
        • Life Westville
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Barcelona, Spain, 08022
        • Centro Médico Teknon
      • Burgos, Spain
        • Hospital Universitario de Burgos
      • Donostia / San Sebastian, Spain
        • Hospital Universitario Donostia
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Valencia, Spain
        • Hospital General Universitario de Valencia
      • Vigo, Spain
        • Hospital Álvaro Cunqueiro
  • Switzerland
      • Zurich, Switzerland
        • Universitatsspital Zurich
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Veterans General Hospital
      • New Taipei City, Taiwan
        • Far Eastern Memorial Hospital
  • United Kingdom
      • Chertsey, United Kingdom
        • St. Peter's Hospital
      • Dudley, United Kingdom
        • Russells Hall Hospital
      • Kettering, United Kingdom
        • Kettering General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Representative population of CRTpatients at clinical sites

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cardiovascular adverse events
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of unplanned hospitalization for cardiovascular cause
throughout study duration, average of 3.5 years; annual evaluations
Number of patient deaths
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all-cause mortality
throughout study duration, average of 3.5 years; annual evaluations
Number of all cause hospitalization
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all cause hospitalization
throughout study duration, average of 3.5 years; annual evaluations
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
throughout study duration, average of 3.5 years; annual evaluations
Number of patients with cerebrovascular events
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of cerebrovascular events requiring hospitalization
throughout study duration, average of 3.5 years; annual evaluations
Number of all adverse device effects
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all adverse device effects
throughout study duration, average of 3.5 years; annual evaluations
Number of all device deficiencies
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all device deficiencies
throughout study duration, average of 3.5 years; annual evaluations
Assessment of patients benefit from CRT
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Documentation of NYHA classification [I-IV]
throughout study duration, average of 3.5 years; annual evaluations
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
throughout study duration, average of 3.5 years; annual evaluations
Documentation of LVEF
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Left ventricular ejection fraction [%]
throughout study duration, average of 3.5 years; annual evaluations
Documentation of LVESV
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Left ventricular end-systolic volume [ml]
throughout study duration, average of 3.5 years; annual evaluations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Actual)

September 22, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data in planned to be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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