Use of Amiodarone-Infused CardiaMend (CardiaMend-Amiodarone) Patches for the Prevention of New-Onset Postoperative Atrial Fibrillation (POAF) in Subjects Undergoing Cardiac Surgery
Helios Cardio Inc.
Summary
The goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein). Participating subjects must be 20-85 year old males or females. Up to 80 participants having cardiac surgery at the University of Louisville will be involved in this study. The main questions this study aims to answer are: 1. Is the patch safe? 2. Does the patch lower the rate of atrial fibrillation (irregular heart rhythm) after cardiac surgery? Researchers will compare up to 3 different doses of the amiodarone patches (low, medium and high) to the usual treatment (Standard of Care) to see if there are differences (increases or decreases) in heart rhythms after cardiac surgery across study groups. Participants will be placed in one of 4 study groups: * Standard of Care (20 participants) * Low dose patch (20 participants) * Medium dose patch (20 participants) * High dose patch (20 participants) Participants will be monitored closely by their doctor(s) during the study and would: * Agree to participate after having their doctor, or a member of the team, explain the study in detail and allowing them to ask any questions they would like. * Sign an Informed Consent Form which will describe the study and tests in full. * Agree to have their doctor and his/her research team record your medical information, draw blood, and perform electrocardiograms, or EKGs (quick, painless test that measures the electrical activity of the heart) and echocardiograms (image of heart) to monitor their heart. * Agree to receive training on the portable EKG recorder and to use it at home approximately 30 days and 6 months after their surgery to monitor their heart. * Agree to return to the hospital approximately 30 days and 6 months after their surgery for a study visit. Participant involvement will be approximately 7 months total.
Description
The purpose of this study is to determine the safety of a drug-device treatment for the prevention of postoperative atrial fibrillation following open heart surgery. Approximately a quarter of patients will develop atrial fibrillation after open heart surgery. Atrial fibrillation is a type of irregular heart rhythm or arrhythmia, in which the heart does not pump effectively. This can lead to problems such as stroke, palpitations (an abnormal heart rhythm that can feel like your heart is racing or pounding) and prolonged hospital stays. The goal of this study is to determine if the application…
Eligibility
- Age range
- 20–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects 20-85 years old. * Subjects able to give voluntary written informed consent, who understand and are willing to comply with study-related procedures. * Subjects scheduled to undergo open-chest cardiac surgery via complete median sternotomy. * Subjects in sinus rhythm at the time of office visit and during prior EKG (note: continuous EKG monitoring for 48 hours is not required). Exclusion Criteria: * Subjects unable to give voluntary written informed consent, unlikely to cooperate, or legally incompetent, including subjects institutionalized by court or official…
Interventions
- Combination ProductThe intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)
Intervention includes a topical, atrial-specific, amiodarone infused CardiaMend patch in the operating room and applied onto the epicardial surface biatrially
Location
- University of LouisvilleLouisville, Kentucky