Non-valvular atrial fibrillation that the catheter ablation is undergone
Conditions
Interventions
Administration of dabigatran
Administration of walfarin
Sponsors
Research group of anticoagulation therapy for NVAF ablation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1_Patients who undergo the first catheter ablation for non-valvular atrial fibrillation 2_Patients with non-valvular atrial fibrillation who is being treated or will be treated with dabigatran or walfarin as anticoagulant therapy to prevent development of ischemic stroke and systemic embolism due to atrial fibrillation 3_20-85 aged patients at the time of obtaining the informed consent 4_Patients who can give the written informed consent by themselves
Exclusion criteria
Exclusion criteria: 1_Patients who have a history of hypersensitivity to any ingredients of dabigatran or walfarin preparation 2_Patients who are suffering from severe renal disorder (creatinine clearance<30 mL/min) including hemodialysis patients 3_Patients who have hemorrhagic symptoms (thrombocytopenic purpura, bleeding tendency caused by vascular defect,hemophilia and other impaired blood coagulation,menstrual period,at the time of operation,gastrointestinal tract ulcer,urinary tract bleeding, hemoptysis, abortion and premature birth, puerperant associated with genital bleeding and intracranial bleeding), hemorrhagic diathesis and hemostatic disorder 4_Patients who have any organic lesion posing a clinically important risk for bleeding (including the onset of hemorrhagic stroke within the past 6 months) 5_Patients who are placing a spinal/epidural catheter 6_Patients who are receiving(oral) itraconazole 7_Patients who are pregnant and of child-bearing potential, patients who are breast-feeding or patients who want to get pregnant during the study period 8_Patients who are of bleeding potential (visceral tumor, gastrointestinal diverticulitis, colitis, subacute bacterial endocarditis, severe hypertension, severe diabetes etc.) 9_Patients who have a severe hepatic impairment 10_Patients who underwent the central nervous system operation or suffered from injury with a short history 11_Patients who are receiving vitamin K2 for osteoporosis 12_Patients who are receiving iguratimod 13_Patients who undergo an operation or bloody maneuver except the ablation 14_Patients whom the investigator judges as inappropriate subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Incidence of embolism during perioperative period -Existence or non-existence of atrial thrombus just before the ablation, detected with transesophageal echocardiography or intra-cardiac Echocardiography | — |
Secondary
| Measure | Time frame |
|---|---|
| -Incidence of major bleeding and embolism during the perioperative period -Incidence of major bleeding during the perioperative period -Incidence of all bleeding during the perioperative period -Incidence of life threatening bleeding during the perioperative period -Incidence of bleeding or embolism during the perioperative period and within 6 months after operation -Number of days of hospitalization -Incidence of ischemic stroke (fatal/non-fatal),systemic embolism, pulmonary embolism,acute myocardial infarction,TIA or vascular death (including hemorrhagic death),all cause mortality and their composite endpoint -NCB(net clinical benefit)measured with the composite endpoint consisting of stroke,systemic embolism,pulmonary embolism,acute myocardial infarction,all cause mortality and major hemorrhage -All adverse event | — |
Countries
Japan
Contacts
Public ContactMizuno Harumi
Research group of anticoagulation therapy for NVAF ablation Mebix, Inc.
Outcome results
None listed