About this trial
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.
Eligibility criteria
Qualifiers
Aged ≥18 years;
Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, 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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Amiodarone Hydrochloride 200 MG