Recruiting
Phase 3

Atrial Fibrillation

Sponsor:

Population Health Research Institute

Code:

NCT05841056

Conditions

Atrial Fibrillation New Onset

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amiodarone Hydrochloride 200 MG

Study Details

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.

Conditions

Atrial Fibrillation New Onset

Study ID

NCT05841056

Start date

Jun 13, 2024

Status verified date

May, 2026

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Amiodarone maintenance therapy

Amiodarone 200 mg daily for four weeks

no intervention: No Amiodarone maintenance therapy

No ongoing Amiodarone maintenance therapy for four weeks

Interventions

Amiodarone Hydrochloride 200 MG

200 mg daily for 4 weeks

Primary outcome measure

  • 3 patients per center per month [ Time Frame: 2 years ]
  • Less than 10% cross-over rate [ Time Frame: 28 days ]
  • Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy [ Time Frame: 28 days ]
  • 90% follow-up at 30 days [ Time Frame: At 30 days post randomization date ]
  • Recurrence of atrial fibrillation [ Time Frame: In the 28 days measured by continuous ECG monitor placed on day after the participant finishes their 3-5g of loading dose ]

Central Contacts and Locations

Central contacts

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Principal Investigator:

Emilie Belley-Cote, MD

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1C9

Principal Investigator:

Gianluigi Bisleri, MD

More Information

Sponsor

Population Health Research Institute

Last update posted

Sep 4, 2026

Last verified

May, 2026

Keywords

  • cardiac surgery
  • heart rhythm monitoring
  • amiodarone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2026-09-04.