CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System

Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System

This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

A prospective, international, single arm, multi-center post market clinical follow-up study.

Inclusion Criteria:

• Severe native valve calcific aortic stenosis
• Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator).

Exclusion Criteria:

• Known hypersensitivity to Nitinol (nickel or titanium)
• Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
• Inability to tolerate anticoagulation/antiplatelet therapy