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Recruiting NCT06470022
NCT06470022 Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
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Plain-language summary for patients
| NCT ID | NCT06470022 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Christian Juhl Terkelsen |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,346 participants |
| Start Date | 2024-08-09 |
| Primary Completion | 2026-07-01 |
Trial Parameters
Condition Aortic Stenosis
Sponsor Christian Juhl Terkelsen
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,346
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-09
Completion 2026-07-01
Interventions
Medtronic Evolut FXEdwards Sapien 3 Ultra Resilia
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Brief 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
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