STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillatio
- Conditions
- non-valvular atrial fibrillation
- Registration Number
- JPRN-UMIN000031424
- Lead Sponsor
- ippon Medical School Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 250
Not provided
1) Patients who have symptomatic paroxysmal atrial fibrillation and drug resistant 2) Patients who have Left Atrial Thrombus and left atrial appendage by transthoracic echocardiography, Computed Tomography(CT),Magnetic Resonance Imaging(MRI) 3) Patients who have a tendency to bleed or bleed and are considered to be at high risk of bleeding due to anticoagulation therapy. For other reasons, patients who cannot conduct anticoagulation therapy 4) Patients who are suffering from severe renal disorder (Ccr*<30mL/min) *Cockroft-Gault Equation 5) Patients who have undergone catheter ablation or surgical intervention for AF 6) Patients who have a treatment history with left atrial appendage closure device 7) Patients who have a left atrial diameter;55mm<= with transthoracic echocardiography 8) Patients who have ejection fraction;35%>= with transthoracic echocardiography 9) Persistent non-valvular atrial fibrillation over 10 years 10)Patients who have atrial septal defect 11) Patients who are pregnant and of child-bearing potential 12) Patients who are unlikely to complete research, such as progressive malignant tumor 13) Patients who is being participated or will be participated to other clinical trials 14) Patients who do not agree the study inclusion 15) Patients judged as inappropriate for this study by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The following composite events during observation period 1: Recurrence of ischemic stroke 2: Systemic embolism 3: All cause death 4: Hospitalization by Heart Failure
- Secondary Outcome Measures
Name Time Method <<Secondary Endpoints>> 1: Onset of stroke 2: Recurrence of ischemic stroke 3: Systemic embolism 4: All cause death 5: Cardiovascular death 6: Hospitalization by Heart Failure 7: Any bleeding 8: Onset of intracranial hemorrhage 9: Composite events (all cause death, onset of stroke, systemic embolism, hospitalization by Heart Failure, serious adverse event caused by catheter ablation) <<The other Endpoints>> 1: Modified Rankin scale score and NYHA classification at the end of observation period 2: Maintenance rate of sinus rhythm 3: Changes in Mini-Mental State Examination (MMSE) scores during observation period 4: The continuation rate of Edoxaban 5: Recurrence rate of stroke according to whether or not Edoxaban discontinue 6: Factors which contribute to discontinue Edoxaban