Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

Launched by CHRISTIAN JUHL TERKELSEN · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different heart valve treatments for a condition called aortic stenosis, which is when the heart's aortic valve narrows and makes it harder for blood to flow. The trial compares the Evolut FX valve with the Sapien 3 Ultra Resilia valve to see which one provides better outcomes for patients. If you are over 18 years old and your heart team believes you are suitable for either of these treatments, you might be eligible to participate.

The trial is currently recruiting participants, and it’s important that the medical center doing the trial has a lot of experience with these procedures. If you decide to participate, you will have TAVI (transcatheter aortic valve implantation) done through a small incision in your leg. This is a minimally invasive procedure that typically allows for quicker recovery times. Participants will be closely monitored throughout the trial to assess how well each valve works. If you have any questions about the trial or your eligibility, it's a good idea to talk to your healthcare provider.

Gender

ALL

Eligibility criteria

• 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