Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: Bayer; Boehringer Ingelheim; Bristol-Myers Squibb; Heart and Stroke Foundation of Canada
• Treatments: Anticoagulants; Apixaban; Coagulants; Dabigatran; Rivaroxaban

Criteria

Inclusion Criteria:

• any patient undergoing device surgery (ie. de novo device implant or pulse generator change or lead replacement or pocket revision)

• receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment

• non-rheumatic atrial fibrillation and/or atrial flutter at moderate or high risk of ATE defined as: i) CHA2DS2VASc score greater than or equal to 2 OR ii) CHA2DS2VASc score < 2 with plan for cardioversion or defibrillation threshold testing at time of device surgery

Exclusion Criteria:

• unable or unwilling to provide informed consent

• history of noncompliance of medical therapy

• active device infection

• eGFR < 30 mL/min

• contraindication to NOAC

• rheumatic valvular disease with hemodynamically significant valve lesion

• mechanical heart valve