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

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT03699345
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-09
• Study Start: 2019-01-07
• Primary Completion: 2019-08-14
• Study Completion: 2024-08-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-Cause Mortality	30 days	All-cause mortality at 30 days

Trial Locations

Locations (11)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark

Clinique Pasteur Toulouse; 🇫🇷 Toulouse Cedex 3, France

Johannes Gutenberg Universitaet Mainz; 🇩🇪 Mainz, Germany

Deutsches Herzzentrum Muenchen (DHM); 🇩🇪 Muenchen, Germany

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Vall d'Hebron University Hospital - Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Brighton and Sussex University Hospital; 🇬🇧 Brighton, East Sussex, United Kingdom

Royal Victoria Hospital Belfast; 🇬🇧 Belfast, United Kingdom

Queen Elisabeth Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom

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