EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation

Launched by ELECTROPHYSIOLOGY RESEARCH FOUNDATION · Sep 25, 2015

Keywords

ClinConnect 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 undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices. This study is a randomized, open label, active-controlled trial with an open-label safety extension, designed to compare local and systemic bleeding within 30 days of cardiac rhythm device implant among subjects randomized to continuous Warfarin or interrupted (\<24 hours) Edoxaban. The study will have three p...

Gender

ALL

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