RecruitingPhase 3

Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial

Canada400 participantsStarted 2024-06-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged ≥18 years;
✓. Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, 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 or obstructive 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

What they're measuring

3 patients per center per month

Timeframe: 2 years

Less than 10% cross-over rate

Timeframe: 28 days

Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy

Timeframe: 28 days

90% follow-up at 30 days

Timeframe: At 30 days post randomization date

Trial details

NCT IDNCT05841056

SponsorPopulation Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Ingrid Copland

905-512-4940 start-poaf@phri.ca

View on ClinicalTrials.gov More Atrial Fibrillation New Onset trials