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OpenTrials
Completed

NCT Number: NCT05780320

A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of POAF. However, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a Class IIA recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the Class IIA recommendation. A meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. Finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. Consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preoperative normal sinus rhythm
  • Procedures:
  • CABG
  • CABG + concomitant valve or aortic replacement/repair

Exclusion criteria

  • Emergent operation

Procedures:

  • MAZE or PVI performed
  • Isolated valve replacement or repair
  • Isolated aortic procedures
  • Heart transplant
  • Lung transplant Pre-existing atrial arrhythmias Pre-operative amiodarone use Contraindications to amiodarone use
  • PR interval > 240 ms
  • 2nd or 3rd degree heart block
  • QTc > 550ms
  • 2nd or 3rd degree heart block
  • Liver impairment (INR > 1.7, AST/ALT > 2x normal)
  • Uncontrolled hypothyroidism/hyperthyroidism
  • Interstitial lung disease
  • Allergy to amiodarone

Treatment and study plan

Prophylactic amiodarone and posterior pericardiotomy

Other

Patients after the implementation of the protocol receive postoperative prophylactic amiodarone and a posterior pericardiotomy.

The amiodarone regimen consists of amiodarone 1mg/min x 10 hours (600 mg total) via central line upon arrival to the intensive care unit followed by 400 mg PO BID on postoperative days 1 and 2 followed by 200 mg PO BID on postoperative days 3 and 4 or until discharge, whichever occurs first.

The posterior pericardiotomy occurs during the cardiac procedure.

Primary outcomes

  1. Postoperative atrial fibrillation

    Time frame: Prior to patient discharge or within 30 days after surgery.

    At least 1 minute duration detected by continuous telemetry or 12-lead electrocardiogram.

Secondary outcomes

  1. Operative mortality

    Time frame: Either in-hospital death or death within 30 days of discharge

    Operative mortality as defined by either in-hospital death or death within 30 days of discharge.

  2. Stroke

    Time frame: Either in-hospital or within 30 days of procedure

    Characterized by deficits lasting > 24 hours and/or imaging findings of infarction

  3. Transient ischemic attack

    Time frame: Either in-hospital or within 30 days of procedure

    Characterized by examination findings lasting < 24 hours without associated imaging findings

  4. Initiation of systemic anticoagulation

    Time frame: Either in-hospital or within 30 days of procedure

    New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation

  5. Persistence of atrial fibrillation at discharge

    Time frame: At postoperative surgical visit (around 4-6 weeks)

    Atrial fibrillation as diagnosed by final ECG

  6. Postoperative hospital length of stay

    Time frame: Up to 90 days

    The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge

  7. Readmission

    Time frame: Within 30 days of procedure

    Rates of hospital readmission will be estimated for patients in each of the study intervention groups. Readmissions will be counted in this calculation if patients are admitted to the hospital. Emergency room visits without admission and outpatient visits will not count toward this calculation of readmission rates.

  8. Symptomatic bradycardia

    Time frame: Either in-hospital or within 30 days of procedure

    Symptomatic bradycardia (HR < 55 bpm) requiring intervention

  9. Number of patients with Amiodarone-related pulmonary toxicity

    Time frame: Either in-hospital or within 30 days of procedure

    Clinical diagnosis of amiodarone-related pulmonary toxicity that uses a combination of x-ray findings consistent with known amiodarone-related pulmonary toxicity and clinical findings including shortness of breath, non-productive cough, and other diagnoses have been excluded.

  10. Postoperative pleural effusions requiring intervention

    Time frame: Either in-hospital or within 30 days of procedure

    Postoperative pleural effusions requiring interventions including thoracostomy drainage or surgical drainage

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 22, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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