Aortic StenosisNCT04860752
SAPIEN 3 Ultra EU PMS
An observational study of Aortic Stenosis and Aortic Valve Stenosis, run by Edwards Lifesciences at 37 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 79 years
- Conditions the study is for
- Aortic Stenosis, Aortic Valve Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation (TAVI)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 37 sitesin 10 countries
- Study dates
- 20 Apr 2021to 22 Jul 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who will undergo TAVI with the Edwards SAPIEN 3 Ultra System as part of standard-of-care treatment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
37 sites in 10 countries.
37 sites in 10 countries
Italy8 sites
Ospedale Moscati, Contrada Amoretta
Avellino, 83100
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Irccs Ismett
Palermo, 90127
Ospedale San Camillo
Roma, 00152
Ospedale Santissima Annunziata
Sassari, 07100
Ospedale Mauriziano
Torino, 10128
Azienda ULSS2 Marca Trevigiana
Treviso, 31100
Ospedale Civile Maggiore
Verona, 37126
Germany7 sites
Hdz Bad Oeynhausen
Bad Oeynhausen, 32545
Deutches Herzzentrum Berlin
Berlin, 13353
Universitäres Herz- und Gefäßzentrum UKE Hamburg
Hamburg, 20251
UKSH University Hospital Kiel
Kiel, 24105
Hospital Universitaet Mainz
Mainz, 55131
Deutsches Herzzentrum Muenchen
München, 80636
LMU, Klinikum der Universitaet Meunchen - Großhadern
München, 81377
Spain5 sites
Complexo Hospitalario Universitario Coruna
A Coruña, 15006
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Universitario Valdecilla Santander, Av. de Valdecilla 25
Santander, 39008
Hospital Alvara Cunqueiro, Estrada de Clara Campoamor 341
Vigo, 36213
France4 sites
Clinique St Augustin
Bordeaux, 33000
Institut Hospitalier Jacques Cartier Massy
Massy, 91300
CHU Bordeaux Hôpital Haut-Lévêque
Pessac, 33604
CHU Hopital Charles Nicolle Rouen
Rouen, 76000
Austria3 sites
LKH-Univ. Graz Klinik, Auenbruggerplaz 15
Graz, 8036
Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3
Sankt Pölten, 3100
Medizinische Universitaet Vienna
Vienna, 1090
Portugal3 sites
Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental , Estrada do Forte do Alto do Duque
Lisbon, 1449-005
Hospital Santa Maria
Lisbon, 1649-035
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, 4400-129
United Kingdom3 sites
Leeds General Infirmary
Leeds, LS1 3EX
St Thomas' Hospital
London, SE1 7EH
Oxford John Radcliffe Hospital
Oxford, OX3 9DU
Finland2 sites
Helsinki University Hospital
Helsinki, 00100
Tampere University Hospital, Teiskontie 35
Tampere, 33520
About this study
Official title: SAPIEN 3 Ultra EU Post-Market Observational Study
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.
Read the detailed description
This is a prospective, observational, single-arm, multicentre, post-market study.
- Conditions
- Aortic Stenosis, Aortic Valve Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- Transcatheter aortic valve implantation (TAVI), SAPIEN 3 Ultra THV, Edwards Lifesciences
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation (TAVI)Device
Subjects will undergo TAVI
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Index Hospitalization
Number of days in hospital after the procedure
Measured: Discharge from hospital, expected to be within 1-5 days post-procedure
Secondary outcomes (8)
Death
Number of patients who died
Measured: 1 year
Stroke
Number of patients who had a stroke
Measured: 1 year
New Requirement for Permanent Pacemaker
Number of patients who received a new permanent pacemaker
Measured: 1 year
Aortic Valve Reintervention
Number of patients who required valve reintervention
Measured: 1 year
Aortic Regurgitation
Number of patients who had moderate or greater aortic regurgitation
Measured: At discharge from hospital, expected to be within 1-5 days post-procedure
Mean Gradient
Mean gradient (mmHg)
Measured: At discharge from hospital, expected to be within 1-5 days post-procedure
Effective Orifice Area
Aortic valve area (cm2)
Measured: At discharge from hospital, expected to be within 1-5 days post-procedure
Discharge Location
Number of patients who were discharged to home or self-care (routine discharge)
Measured: At discharge from hospital, expected to be within 1-5 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start20 Apr 2021
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860752
- Sponsor's protocol ID
- 2020-02
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2021
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAPIEN 3 Ultra EU Post-Market Observational Study
- ClinicalTrials.gov ID
- NCT04860752
- Acronym / sponsor ID
- 2020-02
- Conditions
- Aortic Stenosis, Aortic Valve Stenosis
- Keywords
- Transcatheter aortic valve implantation (TAVI), SAPIEN 3 Ultra THV, Edwards Lifesciences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who will undergo TAVI with the Edwards SAPIEN 3 Ultra System as part of standard-of-care treatment.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI)Subjects will undergo TAVI | Device | – |
Primary outcome
Length of Index Hospitalization
Time frame: Discharge from hospital, expected to be within 1-5 days post-procedure
Number of days in hospital after the procedure
8 secondary outcomes
Death
Time frame: 1 year
Stroke
Time frame: 1 year
New Requirement for Permanent Pacemaker
Time frame: 1 year
Aortic Valve Reintervention
Time frame: 1 year
Aortic Regurgitation
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Mean Gradient
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Effective Orifice Area
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Discharge Location
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Aortic Valve Stenosis, run by Edwards Lifesciences at 37 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Italy, Germany, Spain, France, Austria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Index Hospitalization (time frame: Discharge from hospital, expected to be within 1-5 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.