Aortic Valve Stenosis Clinical Trial
Official title:
Evaluation of Cerebral Thrombembolism After TAVR
EARTH-TAVR is a diagnostic multicenter study to evaluate the occurrence and extent of cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after TAVR.
Calcific aortic valve stenosis is the most common cause of aortic stenosis (AS) among adults
in Europe and in the United States. The prevalence of moderate or severe AS was found to be
age-dependent rising from 0.02% in patients aged 18-44 years to 2.8% in patients aged ≥ 75
years. Among patients at prohibitive surgical risk, TAVR has become the treatment of
choice.The safety and efficacy of TAVR compared with medical management and SAVR has been
demonstrated in clinical trials.The composite of the rate of all-cause death or stroke was
27% and 37% in TAVR patients after 1 and 2 years, respectively.Even though parts of the
strokes occur during the peri-procedural period, the patients remain at risk of stroke
throughout the first months after the procedure.
EARTH-TAVR is a diagnostic multicenter study performing in association with the GALILEO trial
(NCT02556203), which is investigating cerebral embolization with MRI and neurocognitive
testing in patients undergoing TAVR, who are treated with anticoagulation (Rivaroxaban/ASS)
or DAPT (Clopidogrel/ASS). GALILEO is a global multicenter, open-label, randomized,
event-driven, active-controlled study comparing a rivaroxaban-based antithrombotic strategy
to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to
optimize clinical outcomes.
Investigators aim to investigate peri-interventional and delayed cerebral embolization in the
early period (3 months) after TAVR and to analyze associations between neurocognitive
parameters and cerebral embolization patterns in patients on different antithrombotic
treatment regimes.
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