Aortic Valve Stenosis Clinical Trial
Official title:
SAPIEN 3 Ultra EU Post-Market Observational Study
| Verified date | June 2023 |
| Source | Edwards Lifesciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.
| Status | Active, not recruiting |
| Enrollment | 500 |
| Est. completion date | July 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 79 Years |
| Eligibility | Inclusion Criteria: 1. Will undergo TAVI with the Edwards SAPIEN 3 Ultra System 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: 1. Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | LKH-Univ. Graz Klinik, Auenbruggerplaz 15 | Graz | |
| Austria | Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3 | St. Poelten | |
| Austria | Medizinische Universitaet Vienna | Vienna | |
| Finland | Helsinki University Hospital | Helsinki | |
| Finland | Tampere University Hospital, Teiskontie 35 | Tampere | |
| France | 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 | |
| Germany | 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 | Muenchen | |
| Germany | LMU, Klinikum der Universitaet Meunchen - Großhadern | München | |
| Italy | 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 | |
| Norway | Oslo Universitetssykehus Rikshospitalet | Oslo | |
| Portugal | 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 | |
| Spain | Complexo Hospitalario Universitario Coruna | Coruna | |
| 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 | |
| Switzerland | Universitatsspital Zurich | Zürich | |
| United Kingdom | Leeds General Infirmary | Leeds | |
| United Kingdom | St Thomas' Hospital | London | |
| United Kingdom | Oxford John Radcliffe Hospital | Oxford |
| Lead Sponsor | Collaborator |
|---|---|
| Edwards Lifesciences |
Austria, Finland, France, Germany, Italy, Norway, Portugal, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Length of index hospitalization | Number of days in hospital after the procedure | Discharge, expected to be within 1-5 days post-procedure |
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