Overview
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Description
The purpose of the "Compare-TAVI" organization is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.
Purpose of present study:
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
- Hypotheses
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- Evolut FX is non-inferior to Edwards Sapien 3 Resilia with regard to the combined endpoint (death, stroke, moderate/severe aortic regurgitation, moderate/severe valve deterioration) between the two valves being compared.
- There is no difference between valves in secondary safety and efficacy endpoints (see below)
- There is no difference in Aortic Regurgitation fraction (ARF) and Effective Orifice Area (EOA) measured by CMR (CMR-substudy, N=166)
- There is no difference in EOA measured invasively during dobutamine stress (hemodynamic substudy, N=440).
- There is no difference in occurrence of Hypoathenuated Leaflet Thickening (HALT) measured by CT (CT-substudy, N=778).
Eligibility
Inclusion Criteria:
- 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 Criteria:
None