Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve

Launched by INSTITUT FÜR PHARMAKOLOGIE UND PRÄVENTIVE MEDIZIN · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term performance and outcomes of a heart valve called the SAPIEN 3 Ultra RESILIA valve, which is used to treat a condition known as aortic stenosis. This condition occurs when the aortic valve in the heart becomes narrowed, making it difficult for blood to flow properly. The study will follow patients for up to 10 years after they receive this valve through a procedure called transcatheter aortic valve replacement (TAVR). The goal is to understand how well the valve works over time and how it affects patients' health.

To be eligible for this trial, participants need to be between the ages of 65 and 85 and have severe aortic stenosis that requires treatment with the SAPIEN 3 Ultra RESILIA valve. They must successfully receive the valve during their procedure without major complications, such as significant bleeding or the need for additional surgery. Although the trial is not yet recruiting participants, those who join can expect regular follow-ups to monitor their heart health and the performance of the valve. Overall, this study aims to gather important information that could help improve treatment options for people with aortic stenosis in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with severe aortic stenosis undergoing transfemoral TAVI with S3UR valve
• • 2. Successful implantation of the S3UR valve
• 3. VARC-3 defined technical succes is defined as:
• • Freedom from mortality
• • Successful access, delivery of the device, and retrieval of the delivery system
• • Correct positioning of a single prosthetic heart valve into the proper anatomical location
• • Freedom from surgery or intervention related to the device ( exluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication
• Exclusion Criteria:
• • -