Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute

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

Treatment groups

400 Participants
are divided into 2 treatment groups