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NCT05543278Not yet recruitingPhase 4

Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Source: ClinicalTrials.gov · Last updated 30 Jun 2026

Brief summary (registry, in English)

Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
242 (estimated)
First submitted
9 Sept 2022
Start date
Jan 2027
Primary completion date
Jan 2028
Lead sponsor
Massachusetts General Hospital
NCT number
NCT05543278

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 242
  • From Jan 2027 to the primary completion date, Jan 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Pre-existing atrial fibrillation or atrial arrhythmias
  • Pre-existing heart block
  • Sick sinus syndrome

Lab values

  • Contraindication to amiodarone use
    • PR interval \> 240 ms
    • QTc \> 550 ms
    • 2nd or 3rd degree heart block
    • Liver impairment (INR \> 1.7, AST/ALT \> 2x normal)
    • Uncontrolled hyperthyroidism or hypothyroidism
    • Interstitial lung disease
    • Pregnancy and/or breastfeeding
    • Known hypersensitivity to any components of amiodarone, including iodine

Other

  • Cardiogenic shock
  • Marked sinus bradycardia
  • Preoperative amiodarone use
  • Emergent operation
  • Planned MAZE or Pulmonary Vein Isolation procedure

Who the study is looking for

  • \>= 18 years of age
  • All genders
  • All non-coronary artery bypass cardiac surgery patients
  • Preoperative normal sinus rhythm

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.