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

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Transcatheter Aortic Valve Replacement (TAVR)

• 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

Arm && Interventions

Group	Intervention	Description
Edwards CENTERA THV	Transcatheter Aortic Valve Replacement (TAVR)	-

Primary Outcome Measures

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

Trial Locations

Locations (11)

Clinique Pasteur Toulouse; 🇫🇷 Toulouse Cedex 3, France

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

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

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

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Johannes Gutenberg Universitaet Mainz; 🇩🇪 Mainz, Germany

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Royal Victoria Hospital Belfast; 🇬🇧 Belfast, United Kingdom

Queen Elisabeth Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark