Severe aortic stenosis
Conditions
Interventions
Administer edoxaban (30mg or 60mg or 15mg /day) antithrombotic therapy for transcatheter aortic valve implantation with aortic stenosis with atrial fibrillation.
C552171, D001241
Sponsors
Kenichi Tsujita
Masanobu Ishii
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 20 years and older 2. Patients with severe aortic stenosis who are scheduled to undergo TAVI 3. Patients who need anticoagulation therapy due to atrial fibrillation 4. Patients with the informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with the contraindications of Edoxaban (A) Patients with a history of hypersensitivity to the components of edoxaban (B) Patients with serious bleeding symptoms (C) Severe liver disease with blood coagulation abnormalities and clinically important bleeding risk (D) Acute bacterial endocarditis (E) Severe renal dysfunction (creatinine clearance less than 15 mL / min) 2. Valvular atrial fibrillation (rheumatic mitral valve stenosis or artificial valve replacement) 3.Patients who judged unsuitable for participating in the study on the following items; (A) High bleeding risk 1). Congenital or acquired hemorrhagic disease 2). Active ulcerative digestive tract disease 3). Thrombocytopenia 4). platelet related diseases 5). History of hemorrhagic stroke within 3 months 6). Severe hypertension with poor control 7). Patients with recent surgical history (etc. brain, spinal cord, ophthalmic) (B) Severe liver disease (C) Pregnant women (D) Lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in maximal leaflet thickness between three months and 1 week after TAVI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Characteristics (area, location, and%reduced leaflet motion (%ELM))of subclinical valve leaflet thrombosis 1 week and 3months after TAVI. 2) Changes of thrombus formation before and after TAVI. 1 To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) evaluated by T-TAS. 2 To measure von Willebrand factor 3To measure anti-Xa activity 3) Differences of wall shear stress, and oscillatory shea r index analyzed by computational fluid dynamics (CFD)1week after TAVI. 4) The factors associated with the maximal leaflet thickness at 1 week and 3 months after TAVI, and the differences. 5) Number of the adverse events 3months after TAVI defined as composite of all-cause death, myocardial infarction, stroke, TIA, acute kidney injury, bleeding complication, vascular complication, new onset of conduct disorder. -Definition of all-cause death: Based on the VARC-2 criteria 1.Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure) 2.Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease 3.All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure 4.All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events 5.Sudden or unwitnessed death 6.Death of unknown cause Non-cardiovascular mortality Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide) -Definition of myocardial infarction: Based on the VARC-2 criteria Peri-procedural MI (99th percentile), a further increase in at least 50% post-procedure is required AND the peak value must exceed the previously stated limit Spontaneous MI (>72h after the index procedure) Any one of the following criteria Detection of | — |
Contacts
Public ContactTsujita Kenichi
Kumamoto University Hospital
Outcome results
None listed