A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Study Type
OBSERVATIONAL
Enrollment
200
Transcatheter aortic valve implantation
Medizinische Universitaet Wien
Vienna, Austria
St. Paul's Hospital Vancouver
Vancouver, British Columbia, Canada
Aarhus University Hospital, Skejby
Aarhus, Denmark
Device success per VARC-3, defined as meeting all of the following:
* Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication * Intended performance of the valve (mean gradient \< 20 mmHg, peak velocity \< 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
Time frame: 30 days
Death
Time frame: 1 year
Stroke
Time frame: 30 days and 1 year
Major vascular complications
Time frame: 30 days
Life threatening bleeding
Time frame: 30 days
New conduction defects requiring permanent pacemaker
Time frame: 30 days
Acute kidney injury stage 2-3
Time frame: 7 days
New onset atrial fibrillation
Time frame: 30 days
Rehospitalization (valve-related or due to worsening heart failure)
Time frame: 1 year
Paravalvular leak
Time frame: 30 days and 1 year
Mean aortic valve gradient
Time frame: 30 days and 1 year
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Helsinki University Hospital
Helsinki, Finland
Charité - Universitätsmedizin Berlin
Berlin, Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Universitares Herzzentrum Hamburg
Hamburg, Germany
Ospedale G. Pasquinucci
Massa, Italy
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Royal Victoria Hospital Belfast
Belfast, United Kingdom
...and 1 more locations