Brief Title
Evaluation of Cerebral Thrombembolism After TAVR
Official Title
Evaluation of Cerebral Thrombembolism After TAVR
Brief Summary
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.
Detailed Description
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
Primary Outcome
Total volume of new cerebral lesions on MRI, 3 months after TAVR versus Baseline
Secondary Outcome
New lesion volume of cerebral embolization in patients treated with ASS and rivaroxaban 10mg OD versus an antiplatelet -based strategy with ASS and clopidogrel.
Condition
Aortic Valve Stenosis
Intervention
MRI, neurocognitive Testing
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
55
Start Date
September 2016
Completion Date
January 2019
Primary Completion Date
January 2019
Eligibility Criteria
Inclusion Criteria: - Man or woman of 18 years of age or older - Via iliofemoral or subclavian access - Provide written IC Exclusion Criteria: - Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant Treatment - Any other indication for continued treatment with any oral anticoagulant (OAC) - Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma) - Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months after randomization (such as coronary, carotid or peripheral stent implantation) - Clinically overt stroke within the last 3 months - Planned coronary or vascular intervention or major surgery - Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher - Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy - Any contraindication for cerebral MRI, in particular: - non-MRI-conditional pacemakers - MRI conditional pacemakers <4 weeks after implant - any metal fragments in the eye - aneurysm clip in the brain - severe claustrophobia
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ulf Landmesser, Prof. Dr., ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02758964
Organization ID
EARTH - TAVR 01
Responsible Party
Principal Investigator
Study Sponsor
Charite University, Berlin, Germany
Collaborators
Bayer
Study Sponsor
Ulf Landmesser, Prof. Dr., Principal Investigator, Charité - Universitätsmedizin Berlin, Department of Cardiology
Verification Date
March 2019