CompletedNot Applicable

Comparison of Eligible TAVI-valves - Cohort B

Denmark1,031 participantsStarted 2020-06-15

Plain-language summary

The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient more than 18 years of age.
✓. Patient eligible for at least 2 valves being implanted routinely at the participating center, 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 at least 15 valves implanted before a valve can be 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.

Percentage of patients with MACE (Major Adverse Cardiovascular Events)

Timeframe: 1 year

NCT IDNCT04443023

SponsorAarhus University Hospital Skejby

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-02