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

Korábbi kezelés

• Planned use of a class I or III anti-arrhythmic drug (other than study drug);

Más betegség

• Documented preoperative history of paroxysmal, persistent or permanent AF;
• 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;

Laborértékek

• 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).

Egyéb

• 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

• Aged ≥18 years;
• Have undergone cardiac surgery including CABG, valve surgery, surgery on the aorta, 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.