Role of MitraClip in the treatment of mitral regurgitation
Research type
Research Study
Full title
Role of MitraClip in the treatment of mitral regurgitation
IRAS ID
216690
Contact name
Paulo Dias Costa
Contact email
Sponsor organisation
Joint Research Enterprise Office, St George’s University of London
Duration of Study in the UK
0 years, 5 months, 27 days
Research summary
“Mitral regurgitation (MR) can be defined as a cause of structural heart disease, where the systolic retrograde blood flow occurs from left ventricle to left atrium, and is one the most frequent structural valve diseases (Enriquez-Sarano, Akins and Vahanian, 2009). In its severe form, the most common form of treatment is through surgery (Iung, 2003; Nkomo et al., 2006). This approach, however, involves a very invasive and convoluted procedure, which could lead to high operative risks and post-operative complications (Whitlow et al., 2012). Additionally, especially in patients with co-morbidities, the risk-benefit is not acceptable, therefore further limiting the application of this procedure to high-risk patients (Perl et al., 2013a). Recently a minimally invasive procedure has been introduced as an alternative to the surgical approach, particularly in high-risk patients. This procedure involves a percutaneous transcatheter approach, with the intention of treating selected patients with moderate to severe secondary or functional MR(Sündermann et al., 2014). This approach constitutes a less invasive and safer alternative for patients with moderate to severe mitral regurgitation. However this is still a relatively recent technology, with practise limited to only a few highly specialised centres in the United Kingdom. Our aim is therefore to evaluate the efficacy of transcatheter mitral valve repair procedure using the MitraClip system. \n \nParticipants will be selected from a department database and information will be added by assessing the Electronic Patient Record (EPR) procedure reports (catheterisation procedure and transthoracic echocardiogram). Doctor’s notes will be use to collect follow-up variables to analyse the procedure efficacy. Relevant study variables will be drawn from previously collected data and include, for example, mitral regugitation grade recorded before the procedure (pre-screening), during the implanting procedure and after the implanting procedure (follow ups). \n \nThis is an educational research project, sponsored by St George’s University of London and conducted at the Royal Brompton and Harefield NHS Foundation Trust (RBHT). This study was designed using an observational, retrospective, cross-sectional methodology. The duration of the study is eight months, occurring between October/2016 (expected; dependent on the necessary approvals) and May/2017. The period of study is defined between January/2012 to December/2015.”
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/2272
Date of REC Opinion
3 Jan 2017
REC opinion
Favourable Opinion