SAPIEN 3 Ultra EU PMS

Completed

• Conditions: Aortic Valve Stenosis; Aortic Stenosis

• Registration Number: NCT04860752
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-27
• Primary Completion: 2024-07-22
• Study Completion: 2024-07-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of index hospitalization	Discharge, expected to be within 1-5 days post-procedure	Number of days in hospital after the procedure

Trial Locations

Locations (37)

Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3; 🇦🇹 St. Poelten, Austria

Clinique St Augustin; 🇫🇷 Bordeaux, France

CHU Hopital Charles Nicolle Rouen; 🇫🇷 Rouen, France

Deutsches Herzzentrum Muenchen; 🇩🇪 Muenchen, Germany

Complexo Hospitalario Universitario Coruna; 🇪🇸 Coruna, Spain

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Universitatsspital Zurich; 🇨🇭 Zürich, Switzerland

LKH-Univ. Graz Klinik, Auenbruggerplaz 15; 🇦🇹 Graz, Austria

CHU Bordeaux Hôpital Haut-Lévêque; 🇫🇷 Pessac, France

Institut Hospitalier Jacques Cartier Massy; 🇫🇷 Massy, France

Deutches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

UKSH University Hospital Kiel; 🇩🇪 Kiel, Germany

Hdz Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, Germany

Universitäres Herz- und Gefäßzentrum UKE Hamburg; 🇩🇪 Hamburg, Germany

Hospital Universitaet Mainz; 🇩🇪 Mainz, Germany

LMU, Klinikum der Universitaet Meunchen - Großhadern; 🇩🇪 München, Germany

Ospedale Moscati, Contrada Amoretta; 🇮🇹 Avellino, Italy

Azienda Ospedaliera Universitaria Federico II; 🇮🇹 Napoli, Italy

Ospedale Santissima Annunziata; 🇮🇹 Sassari, Italy

Irccs Ismett; 🇮🇹 Palermo, Italy

Ospedale San Camillo; 🇮🇹 Roma, Italy

Ospedale Mauriziano; 🇮🇹 Torino, Italy

Ospedale Civile Maggiore; 🇮🇹 Verona, Italy

Azienda ULSS2 Marca Trevigiana; 🇮🇹 Treviso, Italy

Hospital Clinico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Universitario Valdecilla Santander, Av. de Valdecilla 25; 🇪🇸 Santander, Spain

Hospital Alvara Cunqueiro, Estrada de Clara Campoamor 341; 🇪🇸 Vigo, Spain

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Oxford John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Medizinische Universitaet Vienna; 🇦🇹 Vienna, Austria

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Hospital Santa Maria; 🇵🇹 Lisbon, Portugal

Tampere University Hospital, Teiskontie 35; 🇫🇮 Tampere, Finland

Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental , Estrada do Forte do Alto do Duque; 🇵🇹 Lisbon, Portugal

Centro Hospitalar de Vila Nova de Gaia; 🇵🇹 Vila Nova de Gaia, Portugal

Oslo Universitetssykehus Rikshospitalet; 🇳🇴 Oslo, Norway

St Thomas' Hospital; 🇬🇧 London, United Kingdom