The START-POAF pilot study is a prospective, open-label two-arm, randomized controlled trial with blinded assessment of outcomes (PROBE). This pilot study will assess Atrial Fibrillation (AF) recurrence and burden in patients with new-onset AF following cardiac surgery.
Aged ≥18 years;
Have undergone cardiac surgery including CABG, valve surgery, surgery on the aorta, or combinations thereof within 14 days of randomization;
Had new-onset POAF (or flutter), documented by 12-lead ECG or lasting ≥ 1 hour on telemetry. Patients can be in AF or sinus rhythm at the time of randomization;
Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery.
Documented preoperative history of paroxysmal, persistent or permanent AF;
Planned use of a class I or III anti-arrhythmic drug (other than study drug);
Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter);
Known allergy to ECG adhesives;
Parallel
Amiodarone Hydrochloride 200 MG
Drug200 mg daily for 4 weeks
3 patients per center per month
Ability to recruit an average of 3 participants per center per month
Less than 10% cross-over rate
Less than 10% cross-over rate
Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
Greater than and equal to 90% of the intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
90% follow-up at 30 days
Greater than and equal to 90% follow-up at 30 days
Burden of atrial fibrillation
Defined as percent time in atrial fibrillation
Time to first AF > 6 minutes, >6 hours and >24 hours
Time to first AF \> 6 minutes, \>6 hours and \>24 hours reported from the continuous ECG monitor
Participants with at least one episode >6 minutes, >6 hours and >24 hours
Proportion of participants with at least one episode \> 6 minutes, \>6 hours and \>24 hours reported from the continuous ECG
Heart Failure
Number of participants who experience heart failure
Atrial Fibrillation
Number of participants who experience atrial fibrillation
A composite of stroke, myocardial infarction and cardiovascular death
Number of participants who have at least one of the following: stroke, myocardial infarction or cardiovascular death
Major bleeding
Number of participants who experience a major bleed
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