Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography (RETORIC)
Status:
Unknown status
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
Summary
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence
and independent predictors of reduced leaflet motion and valve thrombosis after TAVI
procedure using multimodality imaging strategy comprising cardiac CT, transesophageal
echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will
assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced
leaflet motion and/or thrombosis when compared with those with normal leaflet function. In
addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to
single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy.
The primary outcome of the nested randomized trial will be the presence of reduced leaflet
motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of
ischemic changes in brain demonstrated by MRI.