SAPIEN 3 Ultra EU PMS

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: Completed
• Conditions: Aortic Stenosis; Aortic Valve Stenosis
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation (TAVI)

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

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 Clínico 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
    • Universitätsspital Zürich
• 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Number of patients who died	1 year
Stroke	Number of patients who had a stroke	1 year
New Requirement for Permanent Pacemaker	Number of patients who received a new permanent pacemaker	1 year
Aortic Valve Reintervention	Number of patients who required valve reintervention	1 year
Aortic Regurgitation	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	Mean gradient (mmHg)	At discharge from hospital, expected to be within 1-5 days post-procedure
Effective Orifice Area	Aortic valve area (cm2)	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)	At discharge from hospital, expected to be within 1-5 days post-procedure

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): July 22, 2024
• Study Completion (Actual): July 22, 2024

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Transcatheter aortic valve implantation (TAVI); SAPIEN 3 Ultra THV; Edwards Lifesciences
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID 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