Mechanisms of Leaflet Thrombosis Following TAVI
Research type
Research Study
Full title
Investigation into the Mechanisms of Leaflet Thrombosis Following Trans-Catheter Aortic Valve Implantation: CLOT study
IRAS ID
256622
Contact name
Tiffany Patterson
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Severe aortic stenosis carries an extremely poor prognosis, with 50% mortality at two years. Trans-catheter aortic valve implantation (TAVI) has become an important alternative to surgical aortic valve replacement and shown to be superior in terms of early clinical outcomes for those at high, intermediate and more recently, low surgical risk. However, little is known about durability and recent concerns have been raised regarding detection of subclinical valve leaflet thrombosis and reduced leaflet mobility in the region of 15%. TAVI thrombosis has been reported to lead to early valve failure and increased incidence of thromboembolic stroke. No evidence exists in regard to use of anti-thrombotic therapies post TAVI, with recent data suggesting harm with oral anticoagulation in the absence of atrial fibrillation. TAVI leaflet thrombosis is likely secondary to leaflet characteristics, turbulent flow and pro-thrombotic state. However, we have no indication as to which patients are at greater risk. The aim of this project is twofold. First, to identify a biomarker screening tool for valve thrombosis by performing a pre-procedural clotting screen in this cohort. Secondly, we will compare haemostatic, structural and clinical characteristics of patients with TAVI thrombosis to a matched control cohort without thrombosis. This will enable identification of this at-risk cohort to tailor anti-thrombotic therapies.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
20/EM/0192
Date of REC Opinion
23 Sep 2020
REC opinion
Further Information Favourable Opinion