Clinical trial NCT03366545: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
Official title: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: cardiac resynchronization therapy
CRT
clinical routine
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Representative population of CRTpatients at clinical sites

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.


Eligibility criteria: 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

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