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

Recruiting now · Phase 3

Conditions studied: Atrial Fibrillation New Onset

In brief

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.

Key facts

Study ID

NCT05841056

Run by

Population Health Research Institute

People needed

400

Starts

2024-06-13

Expected to finish

2028-11-30

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Expected to be ready for hospital discharge within 48 h of randomization.

You may not qualify if…

• 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;
• Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR > 240 ms, high-grade AV block).
• Individuals who are pregnant, breastfeeding, or of childbearing potential - female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening

Where it is running

• Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)
• St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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