Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial
Recruiting · NCT05841056 · Interventional (participants receive a specific treatment) · Lead sponsor: Population Health Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Amiodarone Hydrochloride 200 MG
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Expected to be ready for hospital discharge within 48 h of randomization.
Exclusion criteria
- 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 (Total Lung Capacity (TLC) \<50% predicted) or obstructive (Forced Expiry Volume (FEV1) \<49% predicted) 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
2 locations listed.
- Hamilton General Hospital - Hamilton, Ontario, Canada
- St. Michael's Hospital - Toronto, Ontario, Canada