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Active Not Recruiting
NCT06470022
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
Conditions: Aortic Stenosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 1370
Sponsor: Christian Juhl Terkelsen
Location: Department of cardiology, Aarhus University Hospital Aarhus
Summary
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Eligibility Criteria
Inclusion Criteria:
1. Patient more than 18 years of age.
2. Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia according to a TAVI heart team conference.
3. 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.
4. The center volume should be more than 75 cases a year.
5. The patient has given signed informed consent.
6. TAVI performed via the femoral artery.
Exclusion Criteria:
None
Source: ClinicalTrials.gov (NCT06470022). StuddyBuddy aggregates publicly available trial information.
