Phase 3 Atrial Fibrillation Trial, Recruiting NCT05841056 Sponsor: Population Health Research Institute Condition: Atrial Fibrillation
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Phase 3 Atrial Fibrillation Trial, Recruiting

NCT05841056
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People who have had heart surgery — including bypass surgery (CABG), heart valve surgery, replacement of the main artery leaving the heart (ascending aorta), or a combination of these — within the last 14 days
  • People who developed a new irregular heart rhythm called atrial fibrillation (AF) or atrial flutter after surgery, confirmed by a heart tracing (ECG) or by monitoring lasting at least 1 hour; the person may still be in AF or back in normal rhythm at the time of joining the trial
  • People whose treatment plan already includes receiving a loading dose of a heart medication called amiodarone (between 3 and 5 grams) after surgery
  • People who are expected to be ready to leave hospital within 48 hours of joining the trial

Who may not be able to join:

  • People with a documented history of AF before the surgery (whether it came and went, was ongoing, or was permanent)
  • People whose treatment plan includes using another type of heart rhythm medication from a specific class of drugs (Class I or Class III anti-arrhythmics), other than the study drug
  • People who have had a heart transplant, complex surgery for a heart condition present from birth, insertion of a heart assist device on its own, or a procedure to treat AF (either surgical or catheter-based)
  • People with a known allergy to ECG electrode adhesives (the sticky pads used for heart tracings)
  • People for whom amiodarone is not medically safe to use — for example, those with an overactive thyroid, severe lung disease, a heart rhythm condition called Long QT syndrome, certain abnormalities on their ECG (confirm with trial site), or a significant blockage in the heart's electrical system
  • Women who are pregnant, breastfeeding, who could become pregnant and are not using an effective form of contraception throughout the study, or who return a positive pregnancy test at screening

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: William McIntyre, MD, Population Health Research Institute

Phone: 905-512-4940

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Population Health Research Institute
Registry
ClinicalTrials.gov
Start date
13 June 2024
Est. completion
31 August 2028

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

3 patients per center per month; Less than 10% cross-over rate; Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy; 90% follow-up at 30 days

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov