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

Edwards Lifesciences11 sites in 6 countries87 target enrollmentJanuary 7, 2019

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Edwards Lifesciences
Enrollment: 87
Locations: 11
Primary Endpoint: All-Cause Mortality
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

January 7, 2019

End Date

August 20, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Edwards Lifesciences

Responsible Party

Sponsor

Eligibility Criteria

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