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

RecruitingPhase 3

Sponsor: Population Health Research Institute

Conditions: Atrial Fibrillation New Onset

Interventions: Amiodarone Hydrochloride 200 MG

Countries: Canada

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Aged ≥18 years;
2. Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, or combinations thereof within 14 days of randomization;
3. 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;
4. Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery.
5. Expected to be ready for hospital discharge within 48 h of randomization.

Exclusion Criteria:

1. Documented preoperative history of paroxysmal, persistent or permanent AF;
2. Planned use of a class I or III anti-arrhythmic drug (other than study drug);
3. Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter);
4. Known allergy to ECG adhesives;
5. Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR \> 240 ms, high-grade AV block).
6. 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

Locations (2)

Hamilton, Ontario, Canada
Toronto, Ontario, Canada