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.
This is a prospective, observational, single-arm, multicentre, post-market study.
Study Type
OBSERVATIONAL
Enrollment
500
Subjects will undergo TAVI
Length of Index Hospitalization
Number of days in hospital after the procedure
Time frame: Discharge from hospital, expected to be within 1-5 days post-procedure
Death
Number of patients who died
Time frame: 1 year
Stroke
Number of patients who had a stroke
Time frame: 1 year
New Requirement for Permanent Pacemaker
Number of patients who received a new permanent pacemaker
Time frame: 1 year
Aortic Valve Reintervention
Number of patients who required valve reintervention
Time frame: 1 year
Aortic Regurgitation
Number of patients who had moderate or greater aortic regurgitation
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Mean Gradient
Mean gradient (mmHg)
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Effective Orifice Area
Aortic valve area (cm2)
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Discharge Location
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LKH-Univ. Graz Klinik, Auenbruggerplaz 15
Graz, Austria
Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3
Sankt Pölten, Austria
Medizinische Universitaet Vienna
Vienna, Austria
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital, Teiskontie 35
Tampere, Finland
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, France
Hdz Bad Oeynhausen
Bad Oeynhausen, Germany
...and 27 more locations
Number of patients who were discharged to home or self-care (routine discharge)
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure