Testing Amiodarone-Infused CardiaMend Patches to Prevent Irregular Heart Rhythm After Open-Heart Surgery in Adults

What this Trial Is About

This research aims to evaluate a new way to deliver amiodarone, a drug commonly used in heart surgery, by placing a patch containing the drug directly on the heart instead of through an intravenous line. The study focuses on patients aged 20 to 85 undergoing open chest cardiac surgery and aims to determine if the patch is safe and if it can reduce the rate of irregular heart rhythms called postoperative atrial fibrillation POAF after surgery. The treatment is not yet approved by the FDA and involves careful monitoring to assess heart rhythm changes. Participants will be randomly assigned to one of four groups a control group receiving standard care with no patch, or one of three groups receiving low 70 mg, medium 150 mg, or high 300 mg doses of the amiodarone-infused CardiaMend patches. Each participant in the patch groups will have three patches applied to specific areas on the heart during surgery. The patches are designed to deliver the drug directly to the hearts surface to potentially prevent POAF. Throughout the study, participants will be closely monitored by doctors and research staff. They will have blood tests, electrocardiograms EKGs, and echocardiograms to check heart function. Participants will be trained to use a portable EKG recorder at home approximately 30 days and six months after surgery. Follow-up visits will occur at these times to assess heart rhythm and overall health. Total participation will last about seven months, during which safety and heart rhythm outcomes will be carefully recorded and analyzed.

Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects