NCT05780320Completed
A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 242 (actual)
- First submitted
- 28 Feb 2023
- Start date
- 19 Sept 2022
- Primary completion date
- 15 Nov 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT05780320
What you commit to
- Study type: Observational
- Participants enrolled: 242
- From 19 Sept 2022 to the primary completion date, 15 Nov 2024
- 1 site in 1 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
- Heart transplant
- Lung transplant Pre-existing atrial arrhythmias Pre-operative amiodarone use Contraindications to amiodarone use
- 2nd or 3rd degree heart block
- 2nd or 3rd degree heart block
- Interstitial lung disease
- Allergy to amiodarone
Lab values
- QTc \> 550ms
- Liver impairment (INR \> 1.7, AST/ALT \> 2x normal)
Other
- Emergent operation
- Procedures:
- MAZE or PVI performed
- Isolated valve replacement or repair
- Isolated aortic procedures
- PR interval \> 240 ms
- Uncontrolled hypothyroidism/hyperthyroidism
Who the study is looking for
- Preoperative normal sinus rhythm
- Procedures:
- CABG
- CABG + concomitant valve or aortic replacement/repair
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.