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

Edwards Lifesciences

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: Transcatheter Aortic Valve Replacement (TAVR)

Study type: Observational

Funder types: Industry

Identifiers

NCT03699345

2017-07

Details and patient eligibility

About

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.

Full description

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

Enrollment: 87 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

87 participants in 1 patient group

Edwards CENTERA THV

Treatment:

Device: Transcatheter Aortic Valve Replacement (TAVR)