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Clinical Trials/NCT05780320
NCT05780320
Completed
Not Applicable

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

Massachusetts General Hospital1 site in 1 country242 target enrollmentSeptember 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation New Onset
Sponsor
Massachusetts General Hospital
Enrollment
242
Locations
1
Primary Endpoint
Postoperative atrial fibrillation
Status
Completed
Last Updated
4 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 19, 2022
End Date
March 15, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asishana A Osho

Assistant Professor of Surgery

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Preoperative normal sinus rhythm
  • Procedures:
  • 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

Outcomes

Primary Outcomes

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

  • Persistence of atrial fibrillation at discharge(At postoperative surgical visit (around 4-6 weeks))
  • Postoperative hospital length of stay(Up to 90 days)
  • Transient ischemic attack(Either in-hospital or within 30 days of procedure)
  • Symptomatic bradycardia(Either in-hospital or within 30 days of procedure)
  • Operative mortality(Either in-hospital death or death within 30 days of discharge)
  • Readmission(Within 30 days of procedure)
  • Postoperative pleural effusions requiring intervention(Either in-hospital or within 30 days of procedure)
  • Initiation of systemic anticoagulation(Either in-hospital or within 30 days of procedure)
  • Stroke(Either in-hospital or within 30 days of procedure)
  • Number of patients with Amiodarone-related pulmonary toxicity(Either in-hospital or within 30 days of procedure)

Study Sites (1)

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