CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 242 enrolled
Drug / intervention
Prophylactic amiodarone and posterior pericardiotomyother
Likely dose
Not stated in record
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Search/NCT05780320
NCT05780320N/ACompleted

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

Massachusetts General Hospital·observational·Posted Mar 22, 2023·Updated Dec 5, 2025

In Brief

An observational study evaluating Prophylactic amiodarone and posterior pericardiotomy for Atrial Fibrillation New Onset. Completed, enrolled 242 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 22, 2023
Enrollment StartSep 19, 2022
Primary CompletionNov 15, 2024
Study CompletionMar 15, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 3.3 years ago

Interventions

Prophylactic amiodarone and posterior pericardiotomyother

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.