🏛️ Verified NIH Record • Updated 2026-04-10
SAPIEN 3 Ultra System PMCF (NCT04555967)
🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Edwards Lifesciences
🩺 Plain-English Summary (8th-Grade Level)
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Who can join: Review the eligibility criteria below.
Location: Medizinische Universitaet Wien — Vienna
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- Medizinische Universitaet Wien — Vienna,
- St. Paul's Hospital Vancouver — Vancouver, British Columbia
- Aarhus University Hospital, Skejby — Aarhus,
- Helsinki University Hospital — Helsinki,
- Charité - Universitätsmedizin Berlin — Berlin,
- Deutsches Herzzentrum Berlin — Berlin,
- Universitares Herzzentrum Hamburg — Hamburg,
- Ospedale G. Pasquinucci — Massa,
- Universitair Medisch Centrum Utrecht — Utrecht,
- Royal Victoria Hospital Belfast — Belfast,
- King's College Hospital London — London,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.