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

Heart Failure Clinical Trial

— BIO|STREAM HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03366545
• Other study ID #: CR021
• Status: Recruiting
• Start date: May 14, 2018
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Biotronik SE & Co. KG
• Contact: Maria Jung, Dr.
• Phone: +493068905
• Email: bio-stream-hf[@]biotronik.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy (CRT)
Observation and documentation of routine care for CRT patients

Locations

Country	Name	City	State
Australia	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
Austria	Kepler Universitätsklinikum	Linz
Austria	Universitätsklinikum St. Pölten	St. Polten
Austria	Medizinische Universität Wien	Vienna
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	UZ Brussel	Brussels
Belgium	CHR de la Citadelle - Liège	Liège
Czechia	Nemocnice Ceské Budejovice	Ceské Budejovice
Czechia	Fakultní nemocnice Olomouc	Olomouc
Czechia	Institute for Clinical and Experimental Medicine (IKEM)	Praha
France	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	Hopital de la Timone (CHU La Timone)	Marseille
France	Hôpital privé Clairval	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	Centre Hospitalier de Périgeux	Périgueux
France	Hôpital Haut Lévêque	Pessac Cedex
France	Centre Hospitalier Universitaire de Saint-Étienne	Saint-Étienne
France	Centre Hospitalier Mémorial de Saint-Lô	Saint-Lô
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
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	Städtisches Klinikum St.Georg	Leipzig	Sachsen
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
Hungary	State Hospital of Cardiology	Balatonfüred
Hungary	Gottsegen György Országos Kardiológiai Intézet	Budapest
Hungary	Semmelweis Medical University	Budapest
Hungary	The University of Pécs	Pécs
Israel	Assuta Medical Center	Ashdod
Israel	Ben-Gurion University of the Negev	Be'er Sheva
Israel	Wolfson Medical Center	H_olon
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petach Tikva
Israel	Kaplan Medical Center	Re?ovot
Israel	Chaim Sheba Medical Center	Tel HaShomer
Israel	Shamir Medical Center	Zerifin
Italy	Ospedale San Raffaele	Mailand
Italy	Policlinico Casilino	Roma
Japan	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
Latvia	Pauls Stradins Clinical University Hospital	Riga
Poland	Medical University of Lodz	Lódz
Poland	Szpital Kliniczny Przemienienia Panskiego	Poznan
Poland	The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute	Warsaw
Portugal	Hospital de Santa Cruz	Carnaxide
Portugal	Hospital Espirito Santo de Evora	Évora
Portugal	Hospital de Santa Maria	Lisboa
Portugal	Hospital de Santo António	Porto
Singapore	Changi General Hospital	Singapore
Slovakia	SÚSCCH	Banská Bystrica
Slovakia	NÚSCH Bratislava a.s.	Bratislava
Slovakia	East-Slovak Cardiology Institute (VUSCH)	Košice
South Africa	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
Spain	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
Switzerland	Universitätsspital Zürich	Zürich
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	National Yang Ming University Hospital	Yilan City
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cardiovascular adverse events	Number of unplanned hospitalization for cardiovascular cause	throughout study duration, average of 3.5 years; annual evaluations
Primary	Number of patient deaths	Number of all-cause mortality	throughout study duration, average of 3.5 years; annual evaluations
Primary	Number of all cause hospitalization	Number of all cause hospitalization	throughout study duration, average of 3.5 years; annual evaluations
Primary	Number of patients with worsening of heart failure events	Number of unplanned hospitalization for worsening of heart failure	throughout study duration, average of 3.5 years; annual evaluations
Primary	Number of patients with cerebrovascular events	Number of cerebrovascular events requiring hospitalization	throughout study duration, average of 3.5 years; annual evaluations
Primary	Number of all adverse device effects	Number of all adverse device effects	throughout study duration, average of 3.5 years; annual evaluations
Primary	Number of all device deficiencies	Number of all device deficiencies	throughout study duration, average of 3.5 years; annual evaluations
Primary	Assessment of patients benefit from CRT	Documentation of NYHA classification [I-IV]	throughout study duration, average of 3.5 years; annual evaluations
Primary	Number of patient deaths with cardiovascular cause	Number of patient deaths with cardiovascular cause	throughout study duration, average of 3.5 years; annual evaluations
Primary	Documentation of LVEF	Left ventricular ejection fraction [%]	throughout study duration, average of 3.5 years; annual evaluations
Primary	Documentation of LVESV	Left ventricular end-systolic volume [ml]	throughout study duration, average of 3.5 years; annual evaluations