A Study Comparing Edoxaban to Warfarin Therapy When Used for Cardiovascular Implantable Electrical Device Procedures in Patients with a Non-Valve Related Atrial Fibrillation

Overview

About this study

The purpose of this study is to compare the safety and effectiveness of Edoxaban to Warfarin when used in patients with a non-valve related atrial fibrillation undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Komandoor Srivathsan, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20318081

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