Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone

Launched by UNIVERSITY OF CHICAGO · Sep 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach to help prevent a condition called postoperative atrial fibrillation (POAF) in patients who are undergoing heart surgery, such as coronary artery bypass grafting (CABG) or valve repair. The researchers want to see if using a medication called amiodarone, delivered in a specific way during surgery, can help reduce the chances of developing this heart rhythm problem after the operation.

To participate in this study, individuals should be between the ages of 20 and 85, and they must be scheduled for certain types of open-heart surgery. It's important that they are able to understand the study and give their consent to join. Participants will receive standard care during their surgery and will be monitored closely for any heart rhythm issues afterward. If someone has certain medical conditions, like a severe infection or specific heart issues, they may not be eligible to participate. This trial is currently looking for volunteers to help assess how well this treatment works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject aged 20-85 years old.
• • Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures.
• * Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes:
• • Coronary artery bypass graft (CABG) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid)
• • Isolated ascending aortic aneurysm replacement/repair
• • Note: Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own.
• • In sinus rhythm at the time of office visit and prior electrocardiogram (EKG) (note: continuous EKG monitoring for 48 hours is not required).
• Exclusion Criteria:
• • Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with, testing center or investigator.
• • Any condition which could interfere with the subject's ability to comply with the study.
• • Ongoing participation in an interventional clinical study or during the preceding 30 days.
• • Female subjects who are pregnant, breastfeeding, were pregnant within the last three months, or are planning to become pregnant during the course of the study.
• • Active skin or deep infection at the site of implantation.
• • History of chronic wounds or wound-healing disorders.
• • Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
• • Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion).
• • Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
• • Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
• • Disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
• • Subjects with end-stage chronic-renal disease / dialysis.
• • STS (Society of Thoracic Surgeons Score) risk score \>5.5% for 30 day mortality.