A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Device success per VARC-3, defined as meeting all of the following: — 30 days * Technical success
* Freedom from mortality
* Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
* Intended performance of the valve (mean gradient \< 20 mmHg, peak velocity \< 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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