💬In plain words
What the trial is, and whether it could suit you
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:
* Stan
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
* Subjects on the following medications with known interactions with amiodarone: doxorubicin, fosphenytoin, lopinavir-ritonavir, ledipasvir/sofosbuvir, quinidine , procainamide, disopyramide, other Vaughan William class III agents including dofetilide, dronedarone, ibutilide and vernakalant.
* Subjects with coadministration of any medications which cause QT prolongation
* Subjects with implantable cardiac devices (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD), and pacemakers).
* Subjects with a known history of atrial fibrillation or paroxysmal atrial fibrillation.
* Subjects with a history of ablation for atrial fibrillation.
* Subjects already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
* Subjects with a disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
* Subjects with heart failure (BNP\>1000), low ejection fraction (\<35%), end-stage renal disease (on dialysis or GFR\<20).
* Subjects electing to receive an ablative procedure for atrial fibrillation during the index operation.
* Subjects with prior cardiac surgery via sternotomy.
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