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

Edwards Lifesciences87 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement (TAVR)DEVICE

TAVR with the Edwards CENTERA THV System and accessories

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (11)

Aarhus University Hospital, Skejby

Aarhus, Denmark

Clinique Pasteur Toulouse

Toulouse, France

Johannes Gutenberg Universitaet Mainz

Mainz, Germany

Outcomes

Primary Outcomes

All-Cause Mortality

All-cause mortality at 30 days

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.