SAPIEN 3 Ultra EU PMS

Aortic Valve Stenosis Clinical Trial

Official title:

SAPIEN 3 Ultra EU Post-Market Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04860752
• Other study ID #: 2020-02
• Status: Active, not recruiting
• Start date: April 20, 2021
• Est. completion date: July 2024

Study information

• Verified date: June 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Transcatheter Aortic Valve Implantation (TAVI)
Subjects will undergo TAVI

Locations

Country	Name	City	State
Austria	LKH-Univ. Graz Klinik, Auenbruggerplaz 15	Graz
Austria	Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3	St. Poelten
Austria	Medizinische Universitaet Vienna	Vienna
Finland	Helsinki University Hospital	Helsinki
Finland	Tampere University Hospital, Teiskontie 35	Tampere
France	Clinique St Augustin	Bordeaux
France	Institut Hospitalier Jacques Cartier Massy	Massy
France	CHU Bordeaux Hôpital Haut-Lévêque	Pessac
France	CHU Hopital Charles Nicolle Rouen	Rouen
Germany	Hdz Bad Oeynhausen	Bad Oeynhausen
Germany	Deutches Herzzentrum Berlin	Berlin
Germany	Universitäres Herz- und Gefäßzentrum UKE Hamburg	Hamburg
Germany	UKSH University Hospital Kiel	Kiel
Germany	Hospital Universitaet Mainz	Mainz
Germany	Deutsches Herzzentrum Muenchen	Muenchen
Germany	LMU, Klinikum der Universitaet Meunchen - Großhadern	München
Italy	Ospedale Moscati, Contrada Amoretta	Avellino
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Irccs Ismett	Palermo
Italy	Ospedale San Camillo	Roma
Italy	Ospedale Santissima Annunziata	Sassari
Italy	Ospedale Mauriziano	Torino
Italy	Azienda ULSS2 Marca Trevigiana	Treviso
Italy	Ospedale Civile Maggiore	Verona
Norway	Oslo Universitetssykehus Rikshospitalet	Oslo
Portugal	Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental , Estrada do Forte do Alto do Duque	Lisbon
Portugal	Hospital Santa Maria	Lisbon
Portugal	Centro Hospitalar de Vila Nova de Gaia	Vila Nova de Gaia
Spain	Complexo Hospitalario Universitario Coruna	Coruna
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	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
Switzerland	Universitatsspital Zurich	Zürich
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	St Thomas' Hospital	London
United Kingdom	Oxford John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Finland,  France,  Germany,  Italy,  Norway,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of index hospitalization	Number of days in hospital after the procedure	Discharge, expected to be within 1-5 days post-procedure