Study Type
Interventional - Drug
Atrial fibrillation (AF) is the most common complication of cardiac surgery, occurring in up to half of cases. Despite the frequency of post-operative AF (POAF), there is uncertainty and variation in its management. Better evidence is needed to guide the management of these patients, particularly with respect to rhythm control therapy in the weeks and months following surgery.
The Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Randomized Trial will assess whether among patients with new-onset POAF following cardiac surgery, it is feasible to enroll in a randomized trial testing different durations of amiodarone therapy. It will also explore the impact of 2 different durations of amiodarone treatment on the rate of AF in the first 28 days following enrollment, as measured using continuous ECG monitoring.
This trial will enroll 400 patients from 3 Canadian centres. Participants with post-operative AF (POAF) who are expected to receive a loading dose of amiodarone will be randomized. Participants will be randomized to one of two treatment arms; receive amiodarone 200 mg daily for 4 weeks or no maintenance therapy. Randomized participants will wear a continuous ECG monitor for 28 days starting on the day after the participant finishes their 3 – 5 g of amiodarone loading dose. The main exploratory outcome will be the burden of AF (defined as % time in AF) in the first 28 days following enrollment.
About START-POAFInterventional - Drug
Prospective, open-label two-arm randomized controlled trial with blinded assessment of outcomes (PROBE)
1
3
400
2024-2026
PHRI
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