Ensayos clínicos

Inclusion Criteria 

• Established atrial fibrillation and bradycardia on long term (>3 weeks) therapeutic oral anticoagulant with warfarin or another OAC who are undergoing new pacemaker system implant or existing pacemaker system revision
• Newly detected bradycardia
• Tachycardia syndrome and AF who have been recently (< 3 weeks) started on warfarin, have a therapeutic international normalized ratio (INR) and no thrombus on trans-esophageal echocardiogram (TEE) who are undergoing a new pacemaker system implant or revision
• AF and ventricular tachyarrhythmias (VT or VF) or acquired structural heart disease who are candidates for implantable cardioverter-defibrillator (ICD) therapy and are on long term (>3 weeks) therapeutic OAC with warfarin or another OAC who are undergoing new ICD system implant or existing ICD system revision
• Newly detected AF with VT or VF who have been recently (< 3 weeks) started on warfarin, have a therapeutic INR and no thrombus on TEE who are undergoing ICD system implant or revision

Exclusion Criteria

• Clinically significant valvular heart disease 
• Require cardiovascular implantable electrical device (CIED) lead extraction e.g. for device site infection, endocarditis, leads under advisory or other conditions warranting lead(s) system extraction
• Recent (<1 month) myocardial infarction 
• Documented left atrial (LA) thrombus on TEE
• Contraindications to anticoagulant therapy or adverse event with prior warfarin or edoxaban therapy 
• Creatinine clearance <30ml/min or >95 ml/min 
• Hepatic disease, advanced 
• Recent stroke (<3 months) or thromboembolic event 
• Recent (<3 months) intracranial or other major bleeding event 
• Use of concomitant dual antiplatelet therapy or other oral, subcutaneous or parenteral anticoagulant therapy
• On warfarin without therapeutic INR levels before study entry 
• Have other clinically significant medical condition
• Life expectancy < 1 year 
• Lead extraction procedures