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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Universitat 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-Salpêtrière
      • Pessac, France
        • Hopital Haut Leveque
      • Périgueux, France
        • Centre Hospitalier de Périgeux
      • Saint-Etienne, France
        • Centre Hospitalier Universitaire de Saint-Étienne
      • Saint-Lô, France
        • Centre Hospitalier Mémorial de Saint-Lô
      • Strasbourg, France
        • Hopitaux 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
        • Universitatsklinikum 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
        • Universitatsklinikum Munster
      • Neuss, Germany
        • Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
      • Rothenfelde, Germany
        • Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde
      • Würzburg, Germany
        • Universitatsklinikum Wurzburg
    • 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 Stradins 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 Alvaro 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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Locations

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