An observational study in Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement and Intracranial Embolism, sponsored by Charite University, Berlin, Germany. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-02.
Sponsored by Charite University, Berlin, Germany · Observational
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.
29 studies on the registry are indexed under Intracranial Embolism; none are open to participants now.
Browse Intracranial Embolism studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients 18 years or older wirth aortic valve stenosis receiving TAVR-Intervention.
Exclusion Criteria:
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
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)
Time frame: 3 months after TAVR versus baseline
New lesion volume of cerebral embolization in patients treated with ASS and rivaroxaban 10mg OD versus an antiplatelet -based strategy with ASS and clopidogrel.
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).
Time frame: 3 months post TAVR versus baseline
extent and location of new cerebral lesions early AFTER TAVR and after 3 months
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
Time frame: MRI after TAVR (0-7 days after TAVR) compared to 3 months after TAVR
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.
To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans
Time frame: Before TAVR, post TAVR and after 3 months
Extent and localization of clinically apparent non-cerebral emboli after TAVR
To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)
Time frame: baseline, post TAVR and after 3 months
Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score.
Time frame: Baseline versus 3 months following TAVR
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany