SAPIEN 3 Ultra EU PMS
SAPIEN 3 Ultra EU Post-Market Observational Study
1 other identifier
observational
500
10 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Typical duration for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2021
CompletedFirst Submitted
Initial submission to the registry
April 23, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2024
CompletedResults Posted
Study results publicly available
July 29, 2025
CompletedJuly 29, 2025
July 1, 2025
3.3 years
April 23, 2021
April 30, 2025
July 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of Index Hospitalization
Number of days in hospital after the procedure
Discharge from hospital, expected to be within 1-5 days post-procedure
Secondary Outcomes (8)
Death
1 year
Stroke
1 year
New Requirement for Permanent Pacemaker
1 year
Aortic Valve Reintervention
1 year
Aortic Regurgitation
At discharge from hospital, expected to be within 1-5 days post-procedure
- +3 more secondary outcomes
Interventions
Subjects will undergo TAVI
Eligibility Criteria
Subjects who will undergo TAVI with the Edwards SAPIEN 3 Ultra System as part of standard-of-care treatment.
You may qualify if:
- Will undergo TAVI with the Edwards SAPIEN 3 Ultra System
- Less than 80 years of age at time of the procedure
- Low surgical risk
- Meets clinical and procedural requirements for early discharge
- 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
You may not qualify if:
- Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
- Considered to be part of a vulnerable population
- Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Cannot tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis
- Participating in a drug or device study that has not reached its primary endpoint
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
LKH-Univ. Graz Klinik, Auenbruggerplaz 15
Graz, 8036, Austria
Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3
Sankt Pölten, 3100, Austria
Medizinische Universitaet Vienna
Vienna, 1090, Austria
Helsinki University Hospital
Helsinki, 00100, Finland
Tampere University Hospital, Teiskontie 35
Tampere, 33520, Finland
Clinique St Augustin
Bordeaux, 33000, France
Institut Hospitalier Jacques Cartier Massy
Massy, 91300, France
CHU Bordeaux Hôpital Haut-Lévêque
Pessac, 33604, France
CHU Hopital Charles Nicolle Rouen
Rouen, 76000, France
Hdz Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Deutches Herzzentrum Berlin
Berlin, 13353, Germany
Universitäres Herz- und Gefäßzentrum UKE Hamburg
Hamburg, 20251, Germany
UKSH University Hospital Kiel
Kiel, 24105, Germany
Hospital Universitaet Mainz
Mainz, 55131, Germany
Deutsches Herzzentrum Muenchen
München, 80636, Germany
LMU, Klinikum der Universitaet Meunchen - Großhadern
München, 81377, Germany
Ospedale Moscati, Contrada Amoretta
Avellino, 83100, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Irccs Ismett
Palermo, 90127, Italy
Ospedale San Camillo
Roma, 00152, Italy
Ospedale Santissima Annunziata
Sassari, 07100, Italy
Ospedale Mauriziano
Torino, 10128, Italy
Azienda ULSS2 Marca Trevigiana
Treviso, 31100, Italy
Ospedale Civile Maggiore
Verona, 37126, Italy
Oslo Universitetssykehus Rikshospitalet
Oslo, 0372, Norway
Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental , Estrada do Forte do Alto do Duque
Lisbon, 1449-005, Portugal
Hospital Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, 4400-129, Portugal
Complexo Hospitalario Universitario Coruna
A Coruña, 15006, Spain
Hospital Universitario Clínico San Carlos
Madrid, 28040, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital Universitario Valdecilla Santander, Av. de Valdecilla 25
Santander, 39008, Spain
Hospital Alvara Cunqueiro, Estrada de Clara Campoamor 341
Vigo, 36213, Spain
Universitatsspital Zurich
Zurich, 8091, Switzerland
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
St Thomas' Hospital
London, SE1 7EH, United Kingdom
Oxford John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Edwards THV Clinical Affairs
- Organization
- Edwards Lifesciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2021
First Posted
April 27, 2021
Study Start
April 20, 2021
Primary Completion
July 22, 2024
Study Completion
July 22, 2024
Last Updated
July 29, 2025
Results First Posted
July 29, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share