Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

NCT ID: NCT03366545

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-14

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cardiac Resynchronization Therapy (CRT)

Observation and documentation of routine care for CRT patients

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Canberra Heart Rhythm Foundation

Canberra, , Australia

Site Status TERMINATED

The Canberra Hospital

Canberra, , Australia

Site Status TERMINATED

Lyell McEwin Hospital

Elizabeth Vale, , Australia

Site Status TERMINATED

Liverpool Hospital

Liverpool, , Australia

Site Status TERMINATED

Sydney Adventist Hospital

Sydney, , Australia

Site Status COMPLETED

Westmead Hospital

Westmead, , Australia

Site Status TERMINATED

Westmead Private Hosptial

Westmead, , Australia

Site Status TERMINATED

Kepler Universitätsklinikum

Linz, , Austria

Site Status TERMINATED

Universitätsklinikum St. Pölten

Sankt Pölten, , Austria

Site Status TERMINATED

Medizinische Universität Wien

Vienna, , Austria

Site Status TERMINATED

Imelda Ziekenhuis

Bonheiden, , Belgium

Site Status TERMINATED

UZ Brussel

Brussels, , Belgium

Site Status TERMINATED

CHR de la Citadelle - Liège

Liège, , Belgium

Site Status TERMINATED

Nemocnice České Budějovice

České Budějovice, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Fakultní nemocnice Olomouc

Olomouc, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Institute for Clinical and Experimental Medicine (IKEM)

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

CHU de Brest

Brest, , France

Site Status RECRUITING

Le Centre Hospitalier Universitaire de CAEN

Caen, , France

Site Status RECRUITING

Centre Hospitalier Louis Pasteur

Chartres, , France

Site Status TERMINATED

CHU Dupuytren Limoges

Limoges, , France

Site Status WITHDRAWN

CH Saint Philibert

Lomme, , France

Site Status ACTIVE_NOT_RECRUITING

Centre Hospitalier Lorient

Lorient, , France

Site Status ACTIVE_NOT_RECRUITING

Hopital de la Croix Rousse

Lyon, , France

Site Status WITHDRAWN

Hôpital privé Clairval

Marseille, , France

Site Status TERMINATED

Hopital de la Timone (CHU La Timone)

Marseille, , France

Site Status ACTIVE_NOT_RECRUITING

Hôpital Privé / Institute Jaques Cartier

Massy, , France

Site Status RECRUITING

Clinique les Fontaines

Melun, , France

Site Status RECRUITING

CHU Montpellier

Montpellier, , France

Site Status RECRUITING

Clinique du Millenaire

Montpellier, , France

Site Status TERMINATED

Hôpital privé du Confluent

Nantes, , France

Site Status RECRUITING

Hopital Pitie-Salpetriere

Paris, , France

Site Status RECRUITING

Hôpital Haut Lévêque

Pessac, , France

Site Status TERMINATED

Centre Hospitalier de Périgeux

Périgueux, , France

Site Status TERMINATED

Centre Hospitalier Universitaire de Saint-Étienne

Saint-Etienne, , France

Site Status RECRUITING

Centre Hospitalier Mémorial de Saint-Lô

Saint-Lô, , France

Site Status RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Centre Hospitalier de Rangueil

Toulouse, , France

Site Status TERMINATED

Clinique Pasteur Toulouse

Toulouse, , France

Site Status TERMINATED

Chru de Tours

Tours, , France

Site Status RECRUITING

CH de Valence

Valence, , France

Site Status RECRUITING

Centre Hospitalier Bretagne Atlantique Prosper Chubert

Vannes, , France

Site Status TERMINATED

Städtisches Klinikum St.Georg

Leipzig, Saxony, Germany

Site Status COMPLETED

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Site Status TERMINATED

HDZ Bad Oeynhausen

Bad Oeynhausen, , Germany

Site Status TERMINATED

Maria Heimsuchung - Carita-Klinik Pankow

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Städtisches Klinikum Brandenburg GmbH

Brandenburg, , Germany

Site Status TERMINATED

Krankenhaus Buchholz und Winsen AöR

Buchholz, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Giessen und Marburg

Giessen, , Germany

Site Status ACTIVE_NOT_RECRUITING

KMG Klinikum Güstrow

Güstrow, , Germany

Site Status TERMINATED

Klinikum der Universität Jena

Jena, , Germany

Site Status TERMINATED

Bonifatius Hospital Lingen gGmbH

Lingen, , Germany

Site Status TERMINATED

Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck

Lübeck, , Germany

Site Status TERMINATED

Carl-von-Basedow-Klinikum Saalekreis GmbH

Merseburg, , Germany

Site Status TERMINATED

Johannes Wesling Klinikum Minden

Minden, , Germany

Site Status TERMINATED

Klinikum der LMU / Campus Großhadern

München, , Germany

Site Status COMPLETED

Universitätsklinikum Münster

Münster, , Germany

Site Status TERMINATED

Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH

Neuss, , Germany

Site Status TERMINATED

Klinikum Oldenburg GmbH

Oldenburg, , Germany

Site Status WITHDRAWN

Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde

Rothenfelde, , Germany

Site Status TERMINATED

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status TERMINATED

State Hospital of Cardiology

Balatonfüred, , Hungary

Site Status TERMINATED

Gottsegen György Országos Kardiológiai Intézet

Budapest, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Semmelweis Medical University

Budapest, , Hungary

Site Status ACTIVE_NOT_RECRUITING

The University of Pécs

Pécs, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Assuta Medical Center

Ashdod, , Israel

Site Status TERMINATED

Ben-Gurion University of the Negev

Beersheba, , Israel

Site Status TERMINATED

Wolfson Medical Center

Holon, , Israel

Site Status TERMINATED

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status ACTIVE_NOT_RECRUITING

Meir Medical Center

Kfar Saba, , Israel

Site Status ACTIVE_NOT_RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status ACTIVE_NOT_RECRUITING

Kaplan Medical Center

Rehovot, , Israel

Site Status TERMINATED

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status TERMINATED

Shamir Medical Center

Ẕerifin, , Israel

Site Status TERMINATED

Ospedale San Raffaele

Milan, , Italy

Site Status TERMINATED

Policlinico Casilino

Roma, , Italy

Site Status TERMINATED

Kokura Memorial Hospital

Fukuoka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Hiroshima Prefectural Hospital

Hiroshima, , Japan

Site Status ACTIVE_NOT_RECRUITING

Tokai University Hospital

Kanagawa, , Japan

Site Status ACTIVE_NOT_RECRUITING

Kitasato University Hospital

Sagamihara, , Japan

Site Status ACTIVE_NOT_RECRUITING

Saitama Medical University International Medical Center

Saitama, , Japan

Site Status ACTIVE_NOT_RECRUITING

IMS Tokyo Katsushika General Hospital

Tokyo, , Japan

Site Status WITHDRAWN

Juntendo University Hospital

Tokyo, , Japan

Site Status ACTIVE_NOT_RECRUITING

Fujita Health University Hospital

Toyoake, , Japan

Site Status ACTIVE_NOT_RECRUITING

Saiseikai Yokohamashi Tobu Hospital

Yokohama, , Japan

Site Status WITHDRAWN

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Site Status ACTIVE_NOT_RECRUITING

Medical University of Lodz

Lodz, , Poland

Site Status TERMINATED

Szpital Kliniczny Przemienienia Pańskiego

Poznan, , Poland

Site Status ACTIVE_NOT_RECRUITING

The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute

Warsaw, , Poland

Site Status TERMINATED

Hospital de Santa Cruz

Carnaxide, , Portugal

Site Status TERMINATED

Hospital Espirito Santo de Evora

Evora, , Portugal

Site Status TERMINATED

Hospital de Santa Maria

Lisbon, , Portugal

Site Status ACTIVE_NOT_RECRUITING

Hospital de Santo António

Porto, , Portugal

Site Status TERMINATED

Changi General Hospital

Singapore, , Singapore

Site Status TERMINATED

SÚSCCH

Banská Bystrica, , Slovakia

Site Status TERMINATED

NÚSCH Bratislava a.s.

Bratislava, , Slovakia

Site Status TERMINATED

East-Slovak Cardiology Institute (VUSCH)

Košice, , Slovakia

Site Status TERMINATED

Mediclinic Panorama Hospital

Cape Town, , South Africa

Site Status TERMINATED

Mediclinic Pietermaritzburg

Pietermaritzburg, , South Africa

Site Status ACTIVE_NOT_RECRUITING

Mediclinic Midstream

Pretoria, , South Africa

Site Status TERMINATED

Unitas Hospital

Pretoria, , South Africa

Site Status ACTIVE_NOT_RECRUITING

Gateway Private Hospital

Umhlanga, , South Africa

Site Status TERMINATED

Life Westville

Westville, , South Africa

Site Status TERMINATED

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status ACTIVE_NOT_RECRUITING

Centro Médico Teknon

Barcelona, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario de Bellvitge

Barcelona, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario de Burgos

Burgos, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario Donostia

Donostia / San Sebastian, , Spain

Site Status TERMINATED

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status TERMINATED

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario La Fé

Valencia, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Álvaro Cunqueiro

Vigo, , Spain

Site Status ACTIVE_NOT_RECRUITING

Universitätsspital Zürich

Zurich, , Switzerland

Site Status TERMINATED

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status TERMINATED

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Site Status TERMINATED

National Yang Ming University Hospital

Yilan, , Taiwan

Site Status WITHDRAWN

St. Peter's Hospital

Chertsey, , United Kingdom

Site Status TERMINATED

Russells Hall Hospital

Dudley, , United Kingdom

Site Status TERMINATED

Kettering General Hospital

Kettering, , United Kingdom

Site Status TERMINATED

Royal Cornwall Hospitals NHS Trust

Truro, , United Kingdom

Site Status WITHDRAWN

Countries

Review the countries where the study has at least one active or historical site.

Australia Austria Belgium Czechia France Germany Hungary Israel Italy Japan Latvia Poland Portugal Singapore Slovakia South Africa Spain Switzerland Taiwan United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maria Jung, Dr.

Role: CONTACT

+493068905 ext. 1359

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jacques Mansourati, Prof.

Role: primary

Pierre OLLITRAULT, Dr.

Role: primary

Mohamed-Salem YOUNSI, Dr.

Role: primary

Cyrus Moïni, Dr.

Role: primary

Jean-Luc PASQUIE, Prof.

Role: primary

Daniel Gras, Prof.

Role: primary

Estelle Gandjbakhch, Dr

Role: primary

Antoine Da Costa, Prof.

Role: primary

Laurent Michel, Dr.

Role: primary

Laurence Jesel-More, Dr.

Role: primary

Bertrand Pierre, Dr.

Role: primary

Marie-Pierre Chatel, Dr.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CR021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BIOSTREAM.HF HeartInsight
NCT05761249 COMPLETED
Personalized CRT - PSR
NCT03723265 COMPLETED