Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
- Conditions
- Heart Failure
- Registration Number
- NCT03366545
- Lead Sponsor
- Biotronik SE & Co. KG
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patient deaths throughout study duration, average of 3.5 years; annual evaluations Number of all-cause mortality
Number of patients with cerebrovascular events throughout study duration, average of 3.5 years; annual evaluations Number of cerebrovascular events requiring hospitalization
Assessment of patients benefit from CRT throughout study duration, average of 3.5 years; annual evaluations Documentation of NYHA classification \[I-IV\]
Documentation of LVEF throughout study duration, average of 3.5 years; annual evaluations Left ventricular ejection fraction \[%\]
Number of cardiovascular adverse events throughout study duration, average of 3.5 years; annual evaluations Number of unplanned hospitalization for cardiovascular cause
Number of patients with worsening of heart failure events throughout study duration, average of 3.5 years; annual evaluations Number of unplanned hospitalization for worsening of heart failure
Number of all adverse device effects throughout study duration, average of 3.5 years; annual evaluations Number of all adverse device effects
Number of patient deaths with cardiovascular cause throughout study duration, average of 3.5 years; annual evaluations Number of patient deaths with cardiovascular cause
Number of all cause hospitalization throughout study duration, average of 3.5 years; annual evaluations Number of all cause hospitalization
Number of all device deficiencies throughout study duration, average of 3.5 years; annual evaluations Number of all device deficiencies
Documentation of LVESV throughout study duration, average of 3.5 years; annual evaluations Left ventricular end-systolic volume \[ml\]
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (121)
Canberra Heart Rhythm Foundation
🇦🇺Canberra, Australia
The Canberra Hospital
🇦🇺Canberra, Australia
Lyell McEwin Hospital
🇦🇺Elizabeth Vale, Australia
Liverpool Hospital
🇦🇺Liverpool, Australia
Sydney Adventist Hospital
🇦🇺Sydney, Australia
Westmead Hospital
🇦🇺Westmead, Australia
Westmead Private Hosptial
🇦🇺Westmead, Australia
Kepler Universitätsklinikum
🇦🇹Linz, Austria
Universitätsklinikum St. Pölten
🇦🇹St. Polten, Austria
Medizinische Universität Wien
🇦🇹Vienna, Austria
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
UZ Brussel
🇧🇪Brussels, Belgium
CHR de la Citadelle - Liège
🇧🇪Liège, Belgium
Fakultní nemocnice Olomouc
🇨🇿Olomouc, Czechia
Institute for Clinical and Experimental Medicine (IKEM)
🇨🇿Praha, Czechia
Nemocnice České Budějovice
🇨🇿České Budějovice, Czechia
CHU de Brest
🇫🇷Brest, France
Le Centre Hospitalier Universitaire de CAEN
🇫🇷Caen, France
Centre Hospitalier Louis Pasteur
🇫🇷Chartres, France
CHU Dupuytren Limoges
🇫🇷Limoges, France
CH Saint Philibert
🇫🇷Lomme, France
Centre Hospitalier Lorient
🇫🇷Lorient, France
Hopital de la Croix Rousse
🇫🇷Lyon, France
Hôpital privé Clairval
🇫🇷Marseille, France
Hopital de la Timone (CHU La Timone)
🇫🇷Marseille, France
Hôpital Privé / Institute Jaques Cartier
🇫🇷Massy, France
Clinique les Fontaines
🇫🇷Melun, France
CHU Montpellier
🇫🇷Montpellier, France
Clinique du Millenaire
🇫🇷Montpellier, France
Hôpital privé du Confluent
🇫🇷Nantes, France
Hopital Pitie-Salpetriere
🇫🇷Paris, France
Hôpital Haut Lévêque
🇫🇷Pessac Cedex, France
Centre Hospitalier de Périgeux
🇫🇷Périgueux, France
Centre Hospitalier Mémorial de Saint-Lô
🇫🇷Saint-Lô, France
Centre Hospitalier Universitaire de Saint-Étienne
🇫🇷Saint-Étienne, France
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Centre Hospitalier de Rangueil
🇫🇷Toulouse, France
Clinique Pasteur Toulouse
🇫🇷Toulouse, France
Chru de Tours
🇫🇷Tours, France
CH de Valence
🇫🇷Valence, France
Centre Hospitalier Bretagne Atlantique Prosper Chubert
🇫🇷Vannes, France
Städtisches Klinikum St.Georg
🇩🇪Leipzig, Sachsen, Germany
Zentralklinik Bad Berka GmbH
🇩🇪Bad Berka, Germany
HDZ Bad Oeynhausen
🇩🇪Bad Oeynhausen, Germany
Maria Heimsuchung - Carita-Klinik Pankow
🇩🇪Berlin, Germany
Städtisches Klinikum Brandenburg GmbH
🇩🇪Brandenburg, Germany
Krankenhaus Buchholz und Winsen AöR
🇩🇪Buchholz, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Giessen und Marburg
🇩🇪Gießen, Germany
KMG Klinikum Güstrow
🇩🇪Güstrow, Germany
Klinikum der Universität Jena
🇩🇪Jena, Germany
Bonifatius Hospital Lingen gGmbH
🇩🇪Lingen, Germany
Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
🇩🇪Lübeck, Germany
Carl-von-Basedow-Klinikum Saalekreis GmbH
🇩🇪Merseburg, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Klinikum der LMU / Campus Großhadern
🇩🇪München, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
🇩🇪Neuss, Germany
Klinikum Oldenburg GmbH
🇩🇪Oldenburg, Germany
Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde
🇩🇪Rothenfelde, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
State Hospital of Cardiology
🇭🇺Balatonfüred, Hungary
Gottsegen György Országos Kardiológiai Intézet
🇭🇺Budapest, Hungary
Semmelweis Medical University
🇭🇺Budapest, Hungary
The University of Pécs
🇭🇺Pécs, Hungary
Assuta Medical Center
🇮🇱Ashdod, Israel
Ben-Gurion University of the Negev
🇮🇱Be'er Sheva, Israel
Wolfson Medical Center
🇮🇱H̱olon, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Kaplan Medical Center
🇮🇱Reẖovot, Israel
Chaim Sheba Medical Center
🇮🇱Tel HaShomer, Israel
Shamir Medical Center
🇮🇱Zerifin, Israel
Ospedale San Raffaele
🇮🇹Mailand, Italy
Policlinico Casilino
🇮🇹Roma, Italy
Kokura Memorial Hospital
🇯🇵Fukuoka, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima, Japan
Tokai University Hospital
🇯🇵Kanagawa, Japan
Kitasato University Hospital
🇯🇵Sagamihara, Japan
Saitama Medical University International Medical Center
🇯🇵Saitama, Japan
IMS Tokyo Katsushika General Hospital
🇯🇵Tokio, Japan
Juntendo University Hospital
🇯🇵Tokio, Japan
Fujita Health University Hospital
🇯🇵Toyoake, Japan
Saiseikai Yokohamashi Tobu Hospital
🇯🇵Yokohama, Japan
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Szpital Kliniczny Przemienienia Pańskiego
🇵🇱Poznań, Poland
The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute
🇵🇱Warsaw, Poland
Medical University of Lodz
🇵🇱Łódź, Poland
Hospital de Santa Cruz
🇵🇹Carnaxide, Portugal
Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Hospital de Santo António
🇵🇹Porto, Portugal
Hospital Espirito Santo de Evora
🇵🇹Évora, Portugal
Changi General Hospital
🇸🇬Singapore, Singapore
SÚSCCH
🇸🇰Banská Bystrica, Slovakia
NÚSCH Bratislava a.s.
🇸🇰Bratislava, Slovakia
East-Slovak Cardiology Institute (VUSCH)
🇸🇰Košice, Slovakia
Mediclinic Panorama Hospital
🇿🇦Cape Town, South Africa
Mediclinic Pietermaritzburg
🇿🇦Pietermaritzburg, South Africa
Mediclinic Midstream
🇿🇦Pretoria, South Africa
Unitas Hospital
🇿🇦Pretoria, South Africa
Gateway Private Hospital
🇿🇦Umhlanga, South Africa
Life Westville
🇿🇦Westville, South Africa
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Centro Médico Teknon
🇪🇸Barcelona, Spain
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital Universitario Donostia
🇪🇸Donostia, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario La Fé
🇪🇸Valencia, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
National Yang Ming University Hospital
🇨🇳Yilan City, Taiwan
St. Peter's Hospital
🇬🇧Chertsey, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, United Kingdom
Kettering General Hospital
🇬🇧Kettering, United Kingdom
Royal Cornwall Hospitals NHS Trust
🇬🇧Truro, United Kingdom