CompletedPhase 3

Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

United States523 participantsStarted 2014-05

Plain-language summary

The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.

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.

Enrollment Inclusion Criteria: * Age \> 18 years * Undergoing heart surgery for coronary artery bypass (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations * Hemodynamically stable Randomization Inclusion Criteria * AF that persists for \> 60 minutes or recurrent (more than one) episodes of AF up to 7 days after surgery during the index hospitalization. Exclusion Criteria: * LVAD insertion or heart transplantation * Maze procedure * TAVR * History of or planned mechanical valve replacement * Correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or PFO) * History of AF or AFL * History of AF or AFL ablation * Contraindications to warfarin or amiodarone * Need for long-term anticoagulation * Concurrent participation in an interventional (drug or device) trial

What they're measuring

Total Number of Days in Hospital

Timeframe: Within 60 days of randomization

Trial details

NCT IDNCT02132767

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

Results submitted2016-09-30