Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChristian Juhl Terkelsen
About this trial
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Eligibility criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Medtronic Evolut FX
- Edwards Sapien 3 Ultra Resilia
Treatment groups
1,346 Participants
are divided into 2 treatment groupsSponsors and collaborators
Christian Juhl Terkelsen
Lead sponsor
Aarhus University Hospital Skejby
Sponsor institution
Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark
Collaborator
Source ClinicalTrials.gov