Paravalvular leak post TAVI with Edwards Sapien Valve
Research type
Research Study
Full title
Long term follow up of paravalvular leak post TAVI with Edwards Sapien Valve: An echocardiogram study of how paravalvular leak evolves over time
IRAS ID
167134
Contact name
Simon Redwood
Contact email
Sponsor organisation
Guy's and St Thomas Research and Development Office
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
Trans-catheter aortic valve implantation (TAVI) is now an established treatment for symptomatic severe aortic stenosis in the group of patients who are at a high risk for surgical aortic valve replacement (sAVR).
Unlike surgical aortic valve replacement which involves the de-bulking and removal of the native valve with subsequent implantation of a prosthetic valve, TAVI is the direct implantation of a prosthetic valve over the native valve. This would intuitively leave a greater degree of para-valvular leak (PVL)Registry data has suggested that PVL does not progress with time but more than mild PVL is associated with an increased mortality risk. There is also limited data on the chronological behaviour of paravalvular leak.
We will recruit patients who underwent TAVI at our institution with the Sapiens TAVI valve who had more than mild PVL on discharge.
We will check national databases as to their alive status and will then invite them for an echocardiogram and assess their current symptoms.The echocardiogram results along with a clinician's recommendation will then be forwarded to the patient and GP (with the patient's permission)
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0163
Date of REC Opinion
12 Mar 2015
REC opinion
Favourable Opinion