NCT05841056 Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial
| NCT ID | NCT05841056 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Population Health Research Institute |
| Condition | Atrial Fibrillation New Onset |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-06-13 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2024-06-13 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Aged ≥18 years; 2. Have undergone cardiac surgery including CABG, valve surgery, surgery on the aorta, 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 (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). 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
Contact & Investigator
William McIntyre, MD
PRINCIPAL INVESTIGATOR
Population Health Research Institute
Frequently Asked Questions
Who can join the NCT05841056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation New Onset. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05841056 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT05841056 currently recruiting?
Yes, NCT05841056 is actively recruiting participants. Contact the research team at start-poaf@phri.ca for enrollment information.
Where is the NCT05841056 trial being conducted?
This trial is being conducted at Hamilton, Canada, Toronto, Canada.
Who is sponsoring the NCT05841056 clinical trial?
NCT05841056 is sponsored by Population Health Research Institute. The principal investigator is William McIntyre, MD at Population Health Research Institute. The trial plans to enroll 400 participants.
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