Actively Recruiting
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
Led by Christian Juhl Terkelsen · Updated on 2026-04-28
1346
Participants Needed
1
Research Sites
642 weeks
Total Duration
On this page
Sponsors
C
Christian Juhl Terkelsen
Lead Sponsor
D
Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
CONDITIONS
Official Title
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient more than 18 years of age.
- Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia according to a TAVI heart team conference.
- The center experience for each of the valves considered should be more than 15 cases a year, and the treating physician should have implanted at least 15 of each valve used in the trial.
- The center volume should be more than 75 cases a year.
- The patient has given signed informed consent.
- TAVI performed via the femoral artery.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of cardiology, Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
C
Christian J Terkelsen, Professor
CONTACT
H
Helle Bargsteen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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