Sorin Universal REgistry on Aortic Valve Replacement
Research type
Research Study
Full title
Sorin Universal REgistry on Aortic Valve Replacement
IRAS ID
152866
Contact name
Andrew Chukwuemeka
Contact email
Sponsor organisation
Sorin Group Italia S.r.l
Duration of Study in the UK
13 years, 0 months, 1 days
Research summary
Heart Valve surgery is more accessible to wider patient population, offering improved survival and clinical outcomes. The treatment options for heart valve surgery vary in terms of techniques and medical devices.
The performance of heart valve prostheses can be evaluated through the collection of multiple parameters as outlined below, but not limited to (i) clinical parameters, such as patient demographics and history, procedural and hospital discharge data as well as the short and long term serious adverse events;(ii) available echocardiographic parameters evaluating transvalvular pressure gradients, effective orifice area, and reduction in the ventricular mass.
This registry is an observational global post-market registry following Good Clinical Practices with the objective to collect long term safety and performance data in patients undergoing aortic heart valve replacement.
Worldwide selected centers will be invited to participate in this registry and include their “real-world” patients treated with Sorin Group commercially available aortic devices. Based on specific agreement, participating centers may include patients based on a single or multiple products.REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/1559
Date of REC Opinion
7 Jan 2015
REC opinion
Further Information Favourable Opinion