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

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

Treatments tested in this trial

  • Amiodarone Injection
  • Intraoperative Rapid Atrial Pacing

Treatment groups

600 Participants
are divided into 3 treatment groups

Sponsors and collaborators