ACURATE neo2 PMCF: ACURATE neo2™ Post Market Clinical Follow-up Study
Research type
Research Study
Full title
ACURATE neo2 PMCF: ACURATE neo2™ Post Market Clinical Follow-up Study
IRAS ID
286320
Contact name
Clare Appleby
Contact email
Sponsor organisation
Boston Scientific International SAS
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Aortic Stenosis is the narrowing of the valve, obstructing the flow of blood out of the heart. It is one of the most common and serious valve disease problems. It is associated with high rates of death and complications.
ACURATE neo2™ is a Transfemoral Aortic Valve System used in standard medical practice for the treatment of aortic stenosis. This study is an observation of participants medical condition for a period of time after the initial implant of the device. The purpose of this study is to collect information on the ACURATE neo2 Aortic Valve System when used in standard medical practice to treat symptomatic aortic valve disease.
The number of participants expected to be in the study will be approximately 200 at about 20 study centres in UK, Europe and North America. All participants will be in the study for a period of 5 years once the device is implanted.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
20/LO/1083
Date of REC Opinion
14 Dec 2020
REC opinion
Further Information Favourable Opinion