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Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
The purpose of the "Compare-TAVI" organization is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances. Purpose of present study: To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia. Hypotheses: 1. Evolut FX is non-inferior to Edwards Sapien 3 Resilia with regard to the combined endpoint (death, stroke, moderate/severe aortic regurgitation, moderate/severe valve deterioration) between the two valves being compared. 2. There is no difference between valves in secondary safety and efficacy endpoints (see below) 3. There is no difference in Aortic Regurgitation fraction (ARF) and Effective Orifice Area (EOA) measured by CMR (CMR-substudy, N=166) 4. There is no difference in EOA measured invasively during dobutamine stress (hemodynamic substudy, N=440). 5. There is no difference in occurrence of Hypoathenuated Leaflet Thickening (HALT) measured by CT (CT-substudy, N=778).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Department of cardiology, Aarhus University Hospital
Aarhus, Denmark
Start Date
August 9, 2024
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2036
Last Updated
March 11, 2025
1,346
ESTIMATED participants
Medtronic Evolut FX
DEVICE
Edwards Sapien 3 Ultra Resilia
DEVICE
Lead Sponsor
Christian Juhl Terkelsen
Collaborators
NCT06689839
NCT05511792
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04861805