Using amiodarone patches to prevent irregular heart rhythms after heart surgery
Use of Amiodarone-Infused CardiaMend (CardiaMend-Amiodarone) Patches for the Prevention of New-Onset Postoperative Atrial Fibrillation (POAF) in Subjects Undergoing Cardiac Surgery
This study is testing if using amiodarone patches during heart surgery can help prevent irregular heart rhythms in patients aged 20-85.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Helios Cardio Inc. Industry-sponsored |
| Drugs / interventions | doxorubicin |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06730828 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of amiodarone-infused patches applied directly to the heart during open-heart surgery to prevent postoperative atrial fibrillation. Participants aged 20-85 undergoing cardiac surgery at the University of Louisville will be assigned to one of four groups: standard care or one of three different doses of the amiodarone patch. The study will compare the incidence of atrial fibrillation among these groups to determine if the patches can effectively reduce this complication. The patches are a novel delivery method for a commonly used heart medication, which is not yet FDA approved.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20-85 scheduled for open-chest cardiac surgery who are in sinus rhythm.
Not a fit: Patients who are unable to provide informed consent, have conditions that interfere with compliance, or are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of atrial fibrillation after cardiac surgery, improving recovery and reducing hospital stays.
How similar studies have performed: While the use of amiodarone is common, this specific method of delivery via patches is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Mark S. Slaughter, MD — University of Louisville Hospitals
- Study coordinator: Jaimin Trivedi, MBBS FACC
- Email: jaimin.trivedi@louisville.edu
- Phone: 502-588-7638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.