Actively Recruiting
Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
Led by Helios Cardio Inc. · Updated on 2024-12-12
80
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects 20-85 years old.
- Able to give voluntary written informed consent and willing to comply with study procedures.
- Scheduled to undergo open-chest cardiac surgery via complete median sternotomy.
- In sinus rhythm at the time of office visit and during prior EKG.
You will not qualify if you...
- Unable to give voluntary written informed consent or unlikely to cooperate.
- Participating in another interventional clinical study or have participated within the last 30 days.
- Pregnant, breastfeeding, recently pregnant within 3 months, or planning pregnancy during the study.
- Active skin or deep infection at the implantation site.
- History of chronic wounds or wound-healing disorders.
- Known connective tissue diseases like Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, or Osteogenesis imperfecta.
- Immune-suppressed or immune deficient (except well-managed diabetes).
- On oral or IV systemic corticosteroids or constant anti-inflammatory therapies.
- Taking medications that interact with amiodarone such as doxorubicin, fosphenytoin, lopinavir-ritonavir, ledipasvir/sofosbuvir, quinidine, procainamide, disopyramide, other Vaughan Williams class III agents, or coadministered drugs causing QT prolongation.
- Having implantable cardiac devices like CRT, CRT-D, ICD, or pacemakers.
- History of atrial fibrillation or paroxysmal atrial fibrillation.
- History of ablation for atrial fibrillation.
- Already receiving amiodarone for atrial fibrillation or ventricular arrhythmias.
- Disease of the left pleura, previous intervention in left pleural space, or chest deformity.
- Heart failure with BNP over 1000, ejection fraction below 35%, or end-stage renal disease on dialysis or with GFR below 20.
- Electing to receive an ablative procedure for atrial fibrillation during the surgery.
- Prior cardiac surgery via sternotomy.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
J
Jaimin Trivedi, MBBS FACC
CONTACT
C
Chief Operating Officer, Helios Cardio Inc., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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