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Active (not recruiting) NCT03366545

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

Conditions: Heart Failure

Sponsor: Biotronik SE & Co. KG

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 18
Australia (1)
Canberra Heart Rhythm Foundation
Canberra
Belgium (1)
Imelda Ziekenhuis
Bonheiden
Czech Republic (1)
Nemocnice České Budějovice
České Budějovice
France (1)
CHU de Brest
Brest
Germany (1)
Städtisches Klinikum St.Georg
Leipzig , Saxony
Hungary (1)
State Hospital of Cardiology
Balatonfüred
Israel (1)
Assuta Medical Center
Ashdod
Italy (1)
Ospedale San Raffaele
Milan
Japan (1)
Kokura Memorial Hospital
Fukuoka
Latvia (1)
Pauls Stradins Clinical University Hospital
Riga
Poland (1)
Medical University of Lodz
Lodz
Singapore (1)
Changi General Hospital
Singapore
Slovakia (1)
SÚSCCH
Banská Bystrica
South Africa (1)
Mediclinic Panorama Hospital
Cape Town
Spain (1)
Hospital General Universitario de Alicante
Alicante
Switzerland (1)
Universitätsspital Zürich
Zurich
Taiwan (1)
Kaohsiung Veterans General Hospital
Kaohsiung City
United Kingdom (1)
St. Peter's Hospital
Chertsey
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
14.05.2018
Completion date
30.06.2026
Registry ID
NCT03366545
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.