Study Results
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View full resultsBasic Information
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COMPLETED
500 participants
OBSERVATIONAL
2021-04-20
2024-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Transcatheter Aortic Valve Implantation (TAVI)
Subjects will undergo TAVI
Eligibility Criteria
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Inclusion Criteria
2. Less than 80 years of age at time of the procedure
3. Low surgical risk
4. Meets clinical and procedural requirements for early discharge
5. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent
Exclusion Criteria
2. Considered to be part of a vulnerable population
3. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
4. Cannot tolerate an anticoagulation/antiplatelet regimen
5. Active bacterial endocarditis
6. Participating in a drug or device study that has not reached its primary endpoint
79 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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LKH-Univ. Graz Klinik, Auenbruggerplaz 15
Graz, , Austria
Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3
Sankt Pölten, , Austria
Medizinische Universitaet Vienna
Vienna, , Austria
Helsinki University Hospital
Helsinki, , Finland
Tampere University Hospital, Teiskontie 35
Tampere, , Finland
Clinique St Augustin
Bordeaux, , France
Institut Hospitalier Jacques Cartier Massy
Massy, , France
CHU Bordeaux Hôpital Haut-Lévêque
Pessac, , France
CHU Hopital Charles Nicolle Rouen
Rouen, , France
Hdz Bad Oeynhausen
Bad Oeynhausen, , Germany
Deutches Herzzentrum Berlin
Berlin, , Germany
Universitäres Herz- und Gefäßzentrum UKE Hamburg
Hamburg, , Germany
UKSH University Hospital Kiel
Kiel, , Germany
Hospital Universitaet Mainz
Mainz, , Germany
Deutsches Herzzentrum Muenchen
München, , Germany
LMU, Klinikum der Universitaet Meunchen - Großhadern
München, , Germany
Ospedale Moscati, Contrada Amoretta
Avellino, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Irccs Ismett
Palermo, , Italy
Ospedale San Camillo
Roma, , Italy
Ospedale Santissima Annunziata
Sassari, , Italy
Ospedale Mauriziano
Torino, , Italy
Azienda ULSS2 Marca Trevigiana
Treviso, , Italy
Ospedale Civile Maggiore
Verona, , Italy
Oslo Universitetssykehus Rikshospitalet
Oslo, , Norway
Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental , Estrada do Forte do Alto do Duque
Lisbon, , Portugal
Hospital Santa Maria
Lisbon, , Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, , Portugal
Complexo Hospitalario Universitario Coruna
A Coruña, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario Valdecilla Santander, Av. de Valdecilla 25
Santander, , Spain
Hospital Alvara Cunqueiro, Estrada de Clara Campoamor 341
Vigo, , Spain
Universitatsspital Zurich
Zurich, , Switzerland
Leeds General Infirmary
Leeds, , United Kingdom
St Thomas' Hospital
London, , United Kingdom
Oxford John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-02
Identifier Type: -
Identifier Source: org_study_id
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