RecruitingPhase 1Phase 2NCT06730828

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

Use of Amiodarone-Infused CardiaMend (CardiaMend-Amiodarone) Patches for the Prevention of New-Onset Postoperative Atrial Fibrillation (POAF) in Subjects Undergoing Cardiac Surgery


Sponsor

Helios Cardio Inc.

Enrollment

80 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether placing a heart patch soaked in amiodarone (a medication that helps control heart rhythm) directly on the heart during open-chest surgery can prevent a common complication called post-operative atrial fibrillation (an irregular heartbeat that often develops after cardiac surgery). **You may be eligible if...** - You are 20–85 years old - You are scheduled for open-chest cardiac surgery through a full chest incision (median sternotomy) - Your heart rhythm is normal (sinus rhythm) at the time of your pre-surgery visit - You are able to give informed consent **You may NOT be eligible if...** - You are unable to give informed consent or cooperate with the study - You have a condition that would interfere with your ability to participate - You are already enrolled in another clinical trial - You have a known allergy to amiodarone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

University of Louisville

Louisville, Kentucky, United States

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NCT06730828


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