RecruitingNot ApplicableNCT06470022
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial
Sponsor
Christian Juhl Terkelsen
Enrollment
1,346 participants
Start Date
Aug 9, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria1
- None
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Interventions
DEVICEMedtronic Evolut FX
TAVI performed with Medtronic Evolut FX
DEVICEEdwards Sapien 3 Ultra Resilia
TAVI performed with Edwards Sapien 3 Ultra Resilia
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06470022
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