Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment

Phase 4

Recruiting

Interventions: Drug: Amiodarone Injection
Device: Intraoperative Rapid Atrial Pacing

Brief Summary: Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment. Patients who are not inducible to AF will be treated with standard post-operative care. Patients will be monitored post-operatively to explore the value of intraoperative inducibility of AF to predict POAF and to evaluate whether the combination of intraoperative inducibility and precision amiodarone therapy is effective at reducing the incidence of POAF

Detailed Description: In the operating room, as part of the open heart surgery, the surgeon will stimulate the superior right atrium section of the heart with a pacemaker for 30 seconds just prior to starting the heart and lung bypass machine. The stimulation is done to see how sensitive the heart is to developing atrial fibrillation. This test result will be documented. The procedure will only take 60 seconds out of the entire operation. It does not involve taking any samples of tissue or blood. Following this step, if the heart demonstrates atrial fibrillation for at least 30 seconds then the participant will then be randomized to either receive the prophylactic drug treatment using Amiodarone or to no prophylactic drug administration. The participant has a 50% chance of receiving the FDA approved study drug Amiodarone. The study arms consist of prophylactic drug administration with Amiodarone, No prophylactic drug administration, or no atrial fibrillation reaction after stimulation with the pacemaker. The remainder of the surgical procedure will not be affected, and will follow routine surgical practice.

Recruitment & Eligibility

Inclusion Criteria

Patients scheduled for first-time non-emergent open-heart surgery for coronary artery bypass graft (CABG) revascularization, valvular repair or replacement, combined CABG with valve repair or replacement, or valve sparing aortic root repair
Normal sinus rhythm
No documented history of atrial fibrillation

Exclusion Criteria

Prior surgical procedures involving heart surgery and cardiopulmonary bypass
Any prior documented history of atrial fibrillation, atrial flutter or atrial tachycardia lasting longer than 30 seconds
Prior history of Amiodarone treatment for the management of supraventricular tachy-arrhythmias
Patients requiring surgical treatment of atrial arrhythmias such as pulmonary vein isolation or Maze procedure.

Arm && Interventions

Group	Intervention	Description
Inducible Atrial Fibrillation	Amiodarone Injection	Treatment with Amiodarone
Inducible Atrial Fibrillation - Standard Care	Amiodarone Injection	No initial Amiodarone Treatment unless POAF seen on post operative care unit.
Inducible Atrial Fibrillation - Standard Care	Intraoperative Rapid Atrial Pacing	No initial Amiodarone Treatment unless POAF seen on post operative care unit.
Non-Inducible Atrial Fibrillation	Intraoperative Rapid Atrial Pacing	Amiodarone treatment if POAF seen on post-operative care unit
Inducible Atrial Fibrillation	Intraoperative Rapid Atrial Pacing	Treatment with Amiodarone

Primary Outcome Measures

Name	Time	Method
Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients	30 days	Identify predictors of developing atrial fibrillation in the hope of decreasing post-operative length of stay, the need for anticoagulation, decrease risk of stroke, DVT, and bleeding

Secondary Outcome Measures

Name	Time	Method

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