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

RecruitingPhase 3Ages 18 Years - anyAllPopulation Health Research Institute
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged โ‰ฅ18 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 โ‰ฅ 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
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What it tests

  • Amiodarone Hydrochloride 200 MG
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Where

2 sites
Hamilton General Hospital
Hamilton, Canada
St. Michael's Hospital
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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