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Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

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Trial details

Who runs it
Christian Juhl Terkelsen
Trial code
NCT06470022
Record updated
25 August 2026
Original description
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.Read full original descriptionShow less

Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial

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

Inclusion: 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.

Exclusion: None.

ClinicalTrials.gov NCT06470022