BAViT ver 1
Research type
Research Study
Full title
Contemporary use of Balloon Aortic Valvuloplasty in the TAVI era: a descriptive study of technique, risks, and outcomes of modern techniques and equipment for Balloon Aortic Valvuloplasty - Pilot study
IRAS ID
233056
Contact name
Timothy Williams
Contact email
Sponsor organisation
Brighton and Sussex University Hospitals
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Balloon Aortic Valvuloplasty (BAV) is a recognised treatment for patients with severe aortic stenosis (AS) as a bridge to definitive valve replacement or implantation, or as a symptom relieving procedure. There is good evidence that it improves patients' symptoms from severe AS. There are, however, uncertainties in its current use, regarding both the technique of BAV and the short and long term outcomes with modern management of patients. This study aims to clarify both these questions. We are faced with an aging population and with this more patients will be seen with severe AS that need well tested and cost effective treatment strategies.
Patients will be recruited from within Brighton and Sussex University Hospitals NHS Trust, who have seen the Cardiology Team as either inpatients or outpatients with severe AS, and for whom BAV has been recommmended as a treatment option. This may be as a bridge to definitive valve treatment (surgical replacement or transcatheter valve implantation), or as a symptom relieving procedure only.
Procedures will be performed at the Royal Sussex County Hospital by experienced operators, and patients will be undergoing the BAV procedure as part of their standard clinical care regardless of inclusion in this study. Patients who agree to participate in the study will have additional invasive measurements taken during the procedure of the aortic valve and heart function, as well as Doppler assessment of blood flow to the brain. Both of these procedures enhance standard care. Participants will then be followed up frequently up to 1 year after the procedure with further ultrasound assessment of their heart to assess the effectiveness of the procedure. This will allow us to assess the best way of performing the procedure and assess the longevity of its results.
Funding is from the BSUH research department and Boston Scientific.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/0238
Date of REC Opinion
16 Apr 2018
REC opinion
Further Information Favourable Opinion