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

RecruitingPhase 4Ages 18 Years - anyAllStanford University
NCT03868150 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Amiodarone Injection
  • Intraoperative Rapid Atrial Pacing
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Where

1 site
Stanford University
Stanford, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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