Evaluation of Cerebral Thrombembolism After TAVR (EARTH - TAVR)
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|ClinicalTrials.gov Identifier: NCT02758964|
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment|
|Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Intracranial Embolism||Other: MRI, neurocognitive Testing|
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.
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||Evaluation of Cerebral Thrombembolism After TAVR|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||January 2019|
- Other: MRI, neurocognitive Testing
A cerebral MRI and neurocognitive testing will be performed before TAVR, before hospital discharge and after 3 months
- Total volume of new cerebral lesions on MRI, 3 months after TAVR versus Baseline [ Time Frame: 3 months after TAVR versus baseline ]
Occurrence and extent of cerebral embolization in patients after TAVR measured by total volume of new ischemic cerebral lesions on DWI and FLAIR MRI.
Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the 3 months post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images)
- New lesion volume of cerebral embolization in patients treated with ASS and rivaroxaban 10mg OD versus an antiplatelet -based strategy with ASS and clopidogrel. [ Time Frame: 3 months post TAVR versus baseline ]Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the 3 months post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images).
- extent and location of new cerebral lesions early AFTER TAVR and after 3 months [ Time Frame: MRI after TAVR (0-7 days after TAVR) compared to 3 months after TAVR ]To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be compared 3 months post TAVR versus the post-TAVR MRI scan
- Assessment of different neurocognitive tests (NIHSS-score, MOCA-score, MOT-score, PAL-score, RTI-score, SWM-score, AST-score, CAM-Score); change of sum scores before, after and 3 months after TAVR procedure. [ Time Frame: Before TAVR, post TAVR and after 3 months ]To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans
- Extent and localization of clinically apparent non-cerebral emboli after TAVR [ Time Frame: baseline, post TAVR and after 3 months ]To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)
- Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score. [ Time Frame: Baseline versus 3 months following TAVR ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758964
|Charité - Universitätsmedizin Berlin, Campus Mitte|
|Berlin, Germany, 10117|
|Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin|
|Berlin, Germany, 12203|
|Principal Investigator:||Ulf Landmesser, Prof. Dr.||Charité - Universitätsmedizin Berlin, Department of Cardiology|
|Study Chair:||Matthias Endres, Prof. Dr.||Charité - Universitätsmedizin Berlin, Department of Neurology|
|Study Chair:||Georg M Fröhlich, PD||Charité - Universitätsmedizin Berlin, Department of Cardiology|
|Study Chair:||Volkmar Falk, Professor||German Heart Institute|