EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Edoxaban; Warfarin
Intervention MeSH terms: Warfarin; Edoxaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety
      and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF)
      undergoing clinically indicated implantation or replacement of cardiovascular implantable
      electrical devices.The primary objective is to compare the rates of local and systemic
      bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous
      warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with established atrial fibrillation (AF) and bradycardia on long term (>3
             weeks) therapeutic oral anticoagulant (OAC) with warfarin or another OAC who are
             undergoing new pacemaker system implant or existing pacemaker system revision.

          -  Subjects with newly detected bradycardia -tachycardia syndrome and AF who have been
             recently (less than 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.

          -  Subjects with 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.

          -  Subjects with newly detected AF with VT or VF who have been recently (less than 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

          -  Subjects requiring 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 (<3months) intracranial or other major bleeding event

          -  Use of concomitant dual antiplatelet therapy or other oral, subcutaneous or parenteral
             anticoagulant therapy

          -  Subjects on warfarin without therapeutic INR levels before study entry

          -  Subjects with other clinically significant medical condition

          -  Subjects with life expectancy < 1 year

          -  Lead extraction procedures