CompletedPhase 3

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

Canada663 participantsStarted 2013-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinically significant hematoma

Timeframe: 2 weeks post-op or until resolution of hematoma

Trial details

NCT IDNCT01675076

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

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