Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis

In brief

To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.

Key facts

Study ID

NCT06470022

Run by

Christian Juhl Terkelsen

People needed

1346

Starts

2024-08-09

Expected to finish

2036-12-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 may not qualify if…

• None

Where it is running

• Department of cardiology, Aarhus University Hospital — Aarhus, Denmark (enrolling)

Full record on ClinicalTrials.gov

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