Status:
UNKNOWN
Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
After surgery on the lungs or esophagus, 12-46% of patients experience an irregular heart rhythm called atrial fibrillation. Although usually transient, post-operative atrial fibrillation is associate...
Eligibility Criteria
Inclusion
- Aged 18 years or greater
- Undergoing major non-cardiac pulmonary or esophageal surgery (including esophagectomy, pulmonary wedge resection, lobar resection, pneumonectomy, or gastrectomy)
- POAF prediction score greater than or equal to 4
Exclusion
- Aged less than 18 years
- History of atrial arrhythmia (paroxysmal or persistent), or Wolf-Parkinson-White syndrome (WPW), or 2nd or 3rd degree heart block without a pacemaker
- Current antiarrythmic therapy (including amiodarone, propafenone, sotalol, flecainide, and dronedarone)
- Previous severe adverse reaction or contraindication to amiodarone (including pre-existing interstitial lung disease, or history of hepatotoxicity from amiodarone)
- QTc interval longer than 450ms
- Serum alanine transaminase or aspartate transaminase over 3 times the upper limit of normal, or Child-Pugh class C
- Allergy to amiodarone
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04392921
Start Date
March 7 2022
End Date
April 1 2024
Last Update
March 29 2023
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6