Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
Eligible age
20–85 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Helios Cardio Inc.
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ Subjects unable to give voluntary written informed consent, unlikely to cooperate, or legally incompetent, including subjects institutionalized by court or official order, or in a dependency relationship with testing center or investigator.
- ✕ Subjects with a condition that could interfere with their ability to comply with the study.
- ✕ Subjects participating in an interventional clinical study or who have participated in such study 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 study.
- ✕ Subjects with active skin or deep infection at the site of implantation.
- ✕ Subjects with a history of chronic wounds or wound-healing disorders.
- ✕ Subjects with known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
- ✕ Subjects who are Immune-suppressed or with immune deficiency (properly managed diabetes mellitus is not an exclusion criterion).
Where it's recruiting
Louisville
Source: ClinicalTrials.gov · NCT06730828 · last updated 2024-12-12