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

Last updated: November 22, 2024
Sponsor: Biotronik SE & Co. KG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Cardiac Resynchronization Therapy (CRT)

Clinical Study ID

NCT03366545
CR021
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Planned de novo implantation of or upgrade to a CRT system for treatment accordingto the intended use

  • Patient is able to understand the nature of the registry and has provided writteninformed consent

  • Patient is willing and able to use the CardioMessenger and accepts the HomeMonitoring concept

  • Remote monitoring using the Home Monitoring® platform is planned for the patient

Exclusion

Exclusion Criteria:

  • Standard contraindication for CRT

  • Already or previously implanted with CRT system

  • • Age < 18 years

  • Participation in another interventional clinical investigation other than theregistry-based trials of BIO|STREAM.HF

  • Pregnant or breastfeeding

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: Cardiac Resynchronization Therapy (CRT)
Phase:
Study Start date:
May 14, 2018
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Canberra Heart Rhythm Foundation

    Canberra,
    Australia

    Terminated

  • The Canberra Hospital

    Canberra,
    Australia

    Terminated

  • Lyell McEwin Hospital

    Elizabeth Vale,
    Australia

    Terminated

  • Liverpool Hospital

    Liverpool,
    Australia

    Terminated

  • Sydney Adventist Hospital

    Sydney,
    Australia

    Completed

  • Westmead Hospital

    Westmead, 2145
    Australia

    Terminated

  • Westmead Private Hosptial

    Westmead,
    Australia

    Terminated

  • Kepler Universitätsklinikum

    Linz,
    Austria

    Terminated

  • Universitätsklinikum St. Pölten

    St. Polten,
    Austria

    Terminated

  • Medizinische Universität Wien

    Vienna,
    Austria

    Terminated

  • Imelda Ziekenhuis

    Bonheiden, 2820
    Belgium

    Terminated

  • UZ Brussel

    Brussels, 1090
    Belgium

    Terminated

  • CHR de la Citadelle - Liège

    Liège,
    Belgium

    Terminated

  • Fakultní nemocnice Olomouc

    Olomouc, 77900
    Czechia

    Site Not Available

  • Institute for Clinical and Experimental Medicine (IKEM)

    Praha,
    Czechia

    Site Not Available

  • Nemocnice České Budějovice

    České Budějovice,
    Czechia

    Site Not Available

  • CHU de Brest

    Brest,
    France

    Active - Recruiting

  • Le Centre Hospitalier Universitaire de CAEN

    Caen,
    France

    Active - Recruiting

  • Centre Hospitalier Louis Pasteur

    Chartres,
    France

    Terminated

  • CHU Dupuytren Limoges

    Limoges,
    France

    Site Not Available

  • CH Saint Philibert

    Lomme,
    France

    Site Not Available

  • Centre Hospitalier Lorient

    Lorient,
    France

    Site Not Available

  • Hopital de la Croix Rousse

    Lyon,
    France

    Site Not Available

  • Hopital de la Timone (CHU La Timone)

    Marseille,
    France

    Site Not Available

  • Hôpital privé Clairval

    Marseille, 13009
    France

    Terminated

  • Hôpital Privé / Institute Jaques Cartier

    Massy,
    France

    Active - Recruiting

  • Clinique les Fontaines

    Melun,
    France

    Active - Recruiting

  • CHU Montpellier

    Montpellier,
    France

    Active - Recruiting

  • Clinique du Millenaire

    Montpellier,
    France

    Terminated

  • Hôpital privé du Confluent

    Nantes,
    France

    Active - Recruiting

  • Hopital Pitie-Salpetriere

    Paris,
    France

    Active - Recruiting

  • Hôpital Haut Lévêque

    Pessac Cedex,
    France

    Terminated

  • Centre Hospitalier de Périgeux

    Périgueux,
    France

    Terminated

  • Centre Hospitalier Mémorial de Saint-Lô

    Saint-Lô,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Saint-Étienne

    Saint-Étienne,
    France

    Active - Recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg,
    France

    Active - Recruiting

  • Centre Hospitalier de Rangueil

    Toulouse,
    France

    Terminated

  • Clinique Pasteur Toulouse

    Toulouse,
    France

    Terminated

  • Chru de Tours

    Tours,
    France

    Active - Recruiting

  • CH de Valence

    Valence,
    France

    Active - Recruiting

  • Centre Hospitalier Bretagne Atlantique Prosper Chubert

    Vannes,
    France

    Terminated

  • Städtisches Klinikum St.Georg

    Leipzig, Sachsen 04129
    Germany

    Completed

  • Zentralklinik Bad Berka GmbH

    Bad Berka,
    Germany

    Terminated

  • HDZ Bad Oeynhausen

    Bad Oeynhausen, 32545
    Germany

    Terminated

  • Maria Heimsuchung - Carita-Klinik Pankow

    Berlin, 13187
    Germany

    Site Not Available

  • Städtisches Klinikum Brandenburg GmbH

    Brandenburg,
    Germany

    Terminated

  • Krankenhaus Buchholz und Winsen AöR

    Buchholz,
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen,
    Germany

    Site Not Available

  • Universitätsklinikum Giessen und Marburg

    Gießen, 35392
    Germany

    Site Not Available

  • KMG Klinikum Güstrow

    Güstrow,
    Germany

    Terminated

  • Klinikum der Universität Jena

    Jena, 07743
    Germany

    Terminated

  • Bonifatius Hospital Lingen gGmbH

    Lingen,
    Germany

    Terminated

  • Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck

    Lübeck,
    Germany

    Terminated

  • Carl-von-Basedow-Klinikum Saalekreis GmbH

    Merseburg,
    Germany

    Terminated

  • Johannes Wesling Klinikum Minden

    Minden,
    Germany

    Terminated

  • Klinikum der LMU / Campus Großhadern

    München, 81377
    Germany

    Completed

  • Universitätsklinikum Münster

    Münster,
    Germany

    Terminated

  • Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH

    Neuss,
    Germany

    Terminated

  • Klinikum Oldenburg GmbH

    Oldenburg,
    Germany

    Site Not Available

  • Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde

    Rothenfelde,
    Germany

    Terminated

  • Universitätsklinikum Würzburg

    Würzburg,
    Germany

    Terminated

  • State Hospital of Cardiology

    Balatonfüred,
    Hungary

    Terminated

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest,
    Hungary

    Site Not Available

  • Semmelweis Medical University

    Budapest,
    Hungary

    Site Not Available

  • The University of Pécs

    Pécs,
    Hungary

    Site Not Available

  • Assuta Medical Center

    Ashdod,
    Israel

    Terminated

  • Ben-Gurion University of the Negev

    Be'er Sheva, 84101
    Israel

    Terminated

  • Wolfson Medical Center

    H̱olon,
    Israel

    Terminated

  • Shaare Zedek Medical Center

    Jerusalem,
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba,
    Israel

    Site Not Available

  • Rabin Medical Center

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Reẖovot,
    Israel

    Terminated

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621
    Israel

    Terminated

  • Shamir Medical Center

    Zerifin, 70300
    Israel

    Terminated

  • Ospedale San Raffaele

    Mailand,
    Italy

    Terminated

  • Policlinico Casilino

    Roma,
    Italy

    Terminated

  • Kokura Memorial Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Hiroshima Prefectural Hospital

    Hiroshima,
    Japan

    Site Not Available

  • Tokai University Hospital

    Kanagawa,
    Japan

    Site Not Available

  • Kitasato University Hospital

    Sagamihara,
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Saitama,
    Japan

    Site Not Available

  • IMS Tokyo Katsushika General Hospital

    Tokio,
    Japan

    Site Not Available

  • Juntendo University Hospital

    Tokio,
    Japan

    Site Not Available

  • Fujita Health University Hospital

    Toyoake,
    Japan

    Site Not Available

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama,
    Japan

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga,
    Latvia

    Site Not Available

  • National Heart Institute of Malaysia

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Szpital Kliniczny Przemienienia Pańskiego

    Poznań,
    Poland

    Site Not Available

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

    Warsaw,
    Poland

    Terminated

  • Medical University of Lodz

    Łódź,
    Poland

    Terminated

  • Hospital de Santa Cruz

    Carnaxide,
    Portugal

    Terminated

  • Hospital de Santa Maria

    Lisboa,
    Portugal

    Site Not Available

  • Hospital de Santo António

    Porto,
    Portugal

    Terminated

  • Hospital Espirito Santo de Evora

    Évora,
    Portugal

    Terminated

  • Changi General Hospital

    Singapore,
    Singapore

    Terminated

  • SÚSCCH

    Banská Bystrica,
    Slovakia

    Terminated

  • NÚSCH Bratislava a.s.

    Bratislava,
    Slovakia

    Terminated

  • East-Slovak Cardiology Institute (VUSCH)

    Košice,
    Slovakia

    Terminated

  • Mediclinic Panorama Hospital

    Cape Town,
    South Africa

    Terminated

  • Mediclinic Pietermaritzburg

    Pietermaritzburg,
    South Africa

    Site Not Available

  • Mediclinic Midstream

    Pretoria,
    South Africa

    Terminated

  • Unitas Hospital

    Pretoria,
    South Africa

    Site Not Available

  • Gateway Private Hospital

    Umhlanga,
    South Africa

    Terminated

  • Life Westville

    Westville,
    South Africa

    Terminated

  • Hospital General Universitario de Alicante

    Alicante,
    Spain

    Site Not Available

  • Centro Médico Teknon

    Barcelona, 08022
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario de Burgos

    Burgos,
    Spain

    Site Not Available

  • Hospital Universitario Donostia

    Donostia,
    Spain

    Terminated

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Málaga,
    Spain

    Terminated

  • Hospital General Universitario de Valencia

    Valencia,
    Spain

    Site Not Available

  • Hospital Universitario La Fé

    Valencia,
    Spain

    Site Not Available

  • Hospital Álvaro Cunqueiro

    Vigo,
    Spain

    Site Not Available

  • Universitätsspital Zürich

    Zürich,
    Switzerland

    Terminated

  • Kaohsiung Veterans General Hospital

    Kaohsiung City,
    Taiwan

    Terminated

  • Far Eastern Memorial Hospital

    New Taipei City,
    Taiwan

    Terminated

  • National Yang Ming University Hospital

    Yilan City,
    Taiwan

    Site Not Available

  • St. Peter's Hospital

    Chertsey,
    United Kingdom

    Terminated

  • Russells Hall Hospital

    Dudley,
    United Kingdom

    Terminated

  • Kettering General Hospital

    Kettering,
    United Kingdom

    Terminated

  • Royal Cornwall Hospitals NHS Trust

    Truro,
    United Kingdom

    Site Not Available

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