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ACTIVE NOT RECRUITING
NCT04555967

SAPIEN 3 Ultra System PMCF

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

Summary

A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Official title: SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2020-06-30

Completion Date

2026-11

Last Updated

2025-04-17

Healthy Volunteers

No

Interventions

DEVICE

SAPIEN 3 Ultra System

Transcatheter aortic valve implantation

Locations (11)

Medizinische Universitaet Wien

Vienna, Austria

St. Paul's Hospital Vancouver

Vancouver, British Columbia, Canada

Aarhus University Hospital, Skejby

Aarhus, Denmark

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

King's College Hospital London

London, United Kingdom