NCT05841056RecruitingPhase 3
Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial
Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 4 Apr 2023
- Start date
- 13 Jun 2024
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Population Health Research Institute
- Diseases
- Atrial fibrillation
- NCT number
- NCT05841056
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 13 Jun 2024 to the primary completion date, 31 Dec 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned use of a class I or III anti-arrhythmic drug (other than study drug);
Other illness
- Documented preoperative history of paroxysmal, persistent or permanent AF;
- 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;
Lab values
- 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).
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hamilton General Hospital Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.