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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amiodarone Injection

    Drug

    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.

  • Intraoperative Rapid Atrial Pacing

    Device

    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.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Inducible Atrial FibrillationActive comparator 2 interventions
Group B: Inducible Atrial Fibrillation - Standard CareOther 2 interventions
Group C: Non-Inducible Atrial FibrillationOther 1 intervention

Trial outcomes

Primary outcomes

1

Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients

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

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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