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Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

RECRUITINGN/ASponsored by Christian Juhl Terkelsen
Actively Recruiting
PhaseN/A
SponsorChristian Juhl Terkelsen
Started2024-08-09
Est. completion2025-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06470022

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Aortic StenosisHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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