SAPIEN 3 Ultra EU PMS

July 9, 2025 updated by: Edwards Lifesciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • LKH-Univ. Graz Klinik, Auenbruggerplaz 15
      • St. Poelten, Austria, 3100
        • Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3
      • Vienna, Austria, 1090
        • Medizinische Universitaet Vienna
  • Finland
      • Helsinki, Finland, 00100
        • Helsinki University Hospital
      • Tampere, Finland, 33520
        • Tampere University Hospital, Teiskontie 35
  • France
      • Bordeaux, France, 33000
        • Clinique St Augustin
      • Massy, France, 91300
        • Institut Hospitalier Jacques Cartier Massy
      • Pessac, France, 33604
        • CHU Bordeaux Hopital Haut-Leveque
      • Rouen, France, 76000
        • CHU Hopital Charles Nicolle Rouen
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • HDZ Bad Oeynhausen
      • Berlin, Germany, 13353
        • Deutches Herzzentrum Berlin
      • Hamburg, Germany, 20251
        • Universitäres Herz- und Gefäßzentrum UKE Hamburg
      • Kiel, Germany, 24105
        • UKSH University Hospital Kiel
      • Mainz, Germany, 55131
        • Hospital Universitaet Mainz
      • Muenchen, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • München, Germany, 81377
        • LMU, Klinikum der Universitaet Meunchen - Großhadern
  • Italy
      • Avellino, Italy, 83100
        • Ospedale Moscati, Contrada Amoretta
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Palermo, Italy, 90127
        • Irccs Ismett
      • Roma, Italy, 00152
        • Ospedale San Camillo
      • Sassari, Italy, 07100
        • Ospedale Santissima Annunziata
      • Torino, Italy, 10128
        • Ospedale Mauriziano
      • Treviso, Italy, 31100
        • Azienda ULSS2 Marca Trevigiana
      • Verona, Italy, 37126
        • Ospedale Civile Maggiore
  • Norway
      • Oslo, Norway, 0372
        • Oslo Universitetssykehus Rikshospitalet
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Hospital Santa Maria
      • Lisbon, Portugal, 1449-005
        • Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental , Estrada do Forte do Alto do Duque
      • Vila Nova de Gaia, Portugal, 4400-129
        • Centro Hospitalar de Vila Nova de Gaia
  • Spain
      • Coruna, Spain, 15006
        • Complexo Hospitalario Universitario Coruna
      • Madrid, Spain, 28040
        • Hospital Universitario Clínico San Carlos
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca
      • Santander, Spain, 39008
        • Hospital Universitario Valdecilla Santander, Av. de Valdecilla 25
      • Vigo, Spain, 36213
        • Hospital Alvara Cunqueiro, Estrada de Clara Campoamor 341
  • Switzerland
      • Zürich, Switzerland, 8091
        • Universitatsspital Zurich
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • London, United Kingdom, SE1 7EH
        • St Thomas' Hospital
      • Oxford, United Kingdom, OX3 9DU
        • Oxford John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 79 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Discharge from hospital, expected to be within 1-5 days post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 1 year
Number of patients who died
1 year
Stroke
Time Frame: 1 year
Number of patients who had a stroke
1 year
New Requirement for Permanent Pacemaker
Time Frame: 1 year
Number of patients who received a new permanent pacemaker
1 year
Aortic Valve Reintervention
Time Frame: 1 year
Number of patients who required valve reintervention
1 year
Aortic Regurgitation
Time Frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Number of patients who had moderate or greater aortic regurgitation
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
Mean gradient (mmHg)
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
Aortic valve area (cm2)
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
Number of patients who were discharged to home or self-care (routine discharge)
At discharge from hospital, expected to be within 1-5 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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