Clinical trial NCT04860752: SAPIEN 3 Ultra EU PMS
Official title: SAPIEN 3 Ultra EU Post-Market Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Aortic Valve Stenosis
Keywords: Transcatheter aortic valve implantation (TAVI)
SAPIEN 3 Ultra THV
Edwards Lifesciences
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 500
Sex: ALL
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who will undergo TAVI with the Edwards SAPIEN 3 Ultra System as part of standard-of-care treatment.

Brief summary: 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.

Detailed description: This is a prospective, observational, single-arm, multicentre, post-market study.

Eligibility criteria: 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

Primary outcomes:
measure: Length of index hospitalization
timeFrame: Discharge, expected to be within 1-5 days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Univ. Graz Klinik, Auenbruggerplaz 15
city: St. Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3
city: Vienna
country: Austria
facility: Medizinische Universitaet Vienna
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital, Teiskontie 35
city: Bordeaux
country: France
facility: Clinique St Augustin
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier Massy
city: Pessac
country: France
facility: CHU Bordeaux Hôpital Haut-Lévêque
city: Rouen
country: France
facility: CHU Hopital Charles Nicolle Rouen
city: Bad Oeynhausen
country: Germany
facility: Hdz Bad Oeynhausen
city: Berlin
country: Germany
facility: Deutches Herzzentrum Berlin
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg
city: Kiel
country: Germany
facility: UKSH University Hospital Kiel
city: Mainz
country: Germany
facility: Hospital Universitaet Mainz
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: München
country: Germany
facility: LMU, Klinikum der Universitaet Meunchen - Großhadern
city: Avellino
country: Italy
facility: Ospedale Moscati, Contrada Amoretta
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Palermo
country: Italy
facility: Irccs Ismett
city: Roma
country: Italy
facility: Ospedale San Camillo
city: Sassari
country: Italy
facility: Ospedale Santissima Annunziata
city: Torino
country: Italy
facility: Ospedale Mauriziano
city: Treviso
country: Italy
facility: Azienda ULSS2 Marca Trevigiana
city: Verona
country: Italy
facility: Ospedale Civile Maggiore
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Rikshospitalet
city: Lisbon
country: Portugal
facility: Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental , Estrada do Forte do Alto do Duque
city: Lisbon
country: Portugal
facility: Hospital Santa Maria
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Coruna
country: Spain
facility: Complexo Hospitalario Universitario Coruna
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Murcia
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
city: Santander
country: Spain
facility: Hospital Universitario Valdecilla Santander, Av. de Valdecilla 25
city: Vigo
country: Spain
facility: Hospital Alvara Cunqueiro, Estrada de Clara Campoamor 341
city: Zürich
country: Switzerland
facility: Universitatsspital Zurich
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: Oxford
country: United Kingdom
facility: Oxford John Radcliffe Hospital
Study officials:
References: