SAPIEN 3 Ultra System PMCF

Launched by EDWARDS LIFESCIENCES · Sep 15, 2020

Keywords

ClinConnect Summary

The SAPIEN 3 Ultra System PMCF trial is studying a medical device designed to treat a condition called aortic valve stenosis, which occurs when the heart’s aortic valve becomes narrowed and can’t open properly. This trial is focused on patients who have severe symptoms from this condition and are considered at intermediate or higher risk for traditional heart surgery. The goal is to gather more information about the Edwards SAPIEN 3 Ultra System and how well it works for these patients.

To be eligible for this trial, participants must meet specific health criteria. They should have severe aortic valve stenosis and be evaluated by a specialized team of doctors who determine they cannot safely undergo standard surgery. Participants must also be able to take certain medications and agree to follow the study's procedures, including regular check-ups. If someone joins the trial, they can expect to receive the SAPIEN 3 Ultra device and will be monitored closely to see how well it improves their condition. This trial is currently active but not recruiting new participants, meaning they are not looking for more people to join at this time.

Gender

ALL

Eligibility criteria

• • 1. Subject meets the criteria per the Indication and Contraindications according to the current IFUs.
• • Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator).
• • Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy.
• • 2. Subject has provided written informed consent to comply with all study procedures and follow-up visits