RECRUITINGPhase 4INTERVENTIONAL

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

Assessment of Intra-Operative Atrial Fibrillation Inducibility As a Screening Tool to Prevent Post-Operative Atrial Fibrillation With Prophylaxis Amiodarone

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Amiodarone Injection

Patients stratified into the amiodarone study group were administered amiodarone until day of discharge. Amiodarone administration began intraoperatively with the administration of a 150 mg IV amiodarone loading bolus prior to separation from coronary pulmonary bypass, followed by 1 mg/min IV amiodarone for six hours (360 mg), then 0.5 mg/min IV amiodarone for 18 hours (540 mg), then transitioned to 400 mg oral amiodarone twice a day until discharge. In total, patients in the amiodarone treatment group received 1,050mg of IV amiodarone plus 800mg/day of oral amiodarone thereafter until discharge.

DEVICE

Intraoperative Rapid Atrial Pacing

Intraoperative rapid atrial pacing for 30 seconds after cannulation and prior to initiation of cardiopulmonary bypass by having the surgeon attach insulated forceps to the superior right atrial free wall and connected to a temporary pacemaker to burst pace at a rate of 800 bpm for 30 seconds (pulse width 1.0 ms, output: 20 mA) Patients are monitored for successful atrial fibrillation induction defined as 30 seconds of sustained atrial fibrillation on ECG.

Locations (1)

Stanford University

Stanford, California, United States