SAPIEN 3 Ultra System PMCF

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Aortic Valve Stenosis

Treatments: Device: SAPIEN 3 Ultra System

Study type: Observational

Funder types: Industry

Identifiers

NCT04555967

2018-09

Details and patient eligibility

About

A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Full description

To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 1 patient group

Transcatheter aortic valve implantation

Treatment:

Device: SAPIEN 3 Ultra System