2017-07 Centera PMCF
Research type
Research Study
Full title
Post-Market Clinical Follow-Up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System
IRAS ID
245123
Contact name
Simon Redwood
Contact email
Sponsor organisation
Edwards Lifescience LLC
Duration of Study in the UK
6 years, 0 months, 2 days
Research summary
Aortic Stenosis(AS) is a progressive, debilitating and life-threatening disease if left untreated.It remains the most common cause of adult heart valve disease.
The standard of care therapy for patients suffering from severe AS is aortic valve replacement surgery.
The purpose of this study is to monitor and review device performance and outcomes of the Edwards CENTERA Transcatheter Heart Valve (THV) System in adult patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement. The valve is CE-marked & this study will continue to fulfill safety and surveillance reporting requirements under the European Medical Device Directive.
The commercially available CENTERA THV represents the first self-expanding valve developed by Edwards Lifesciences. The CENTERA THV System is available in three sizes, 23mm, 26mm, and 29mm, and is pre-attached to the delivery catheter.
Eligible patients would be those consented, who are judged to be at high risk for open surgical therapy by their consultant i.e predicted risk of surgical mortality at equal or greater than 8% at 30 days post-operation based on the Society of Thoracic Surgeons(STS) risk score calculator with other co-exisiting conditions & as per the Instructions for Use(IFU).
Transcatheter aortic valve implantation has been recognised as an alternative therapy for surgical replacement. The valve is introduced to the heart via a small flexible tube & this less invasive approach can facilitate less complications & adverse events than surgical options.Patient data will be collected to assess outcomes from the time of consent until discharge from the hospital, 30-days and annually until 5 years following the date of the procedure. Approximately 200 patients will participate in this study from sites mostly in the European Union.
Data collected in this study will be used to support submissions to health economic agencies and to supplement post‐market information on the CENTERA THV when used as intended.
It is unlikely that subjects will receive any direct benefit from participation in this study. Information learned from this study may help other people in the future.REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0727
Date of REC Opinion
27 Jul 2018
REC opinion
Further Information Favourable Opinion