Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Sub… (NCT06730828) | Clinical Trial Compass
RecruitingPhase 1/2
Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
United States80 participantsStarted 2024-12-16
Plain-language 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.
Who can participate
Age range
20 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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).
* Subjects on concomitant or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety, defined as major adverse cardiac and cerebrovascular events (MACCE), up to subject discharge.
Timeframe: From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner