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Amiodarone-Infused CardiaMend Patches for Preventing Irregular Heart Rhythms After Surgery

This study is testing a new way to prevent an irregular heart rhythm called atrial fibrillation (AFib) after open-heart surgery. AFib can cause problems like stroke and longer hospital stays. Researchers are using a patch called CardiaMend, infused with a common heart medication called amiodarone, placed directly on the heart during surgery. This is different from giving amiodarone through an IV. The main goal is to see if the patch is safe and if it can lower the chance of developing AFib after surgery. You may be able to join if you are 20-85 years old, scheduled for open-heart surgery, and in a normal heart rhythm before surgery. Up to 80 participants will be enrolled at the University of Louisville.

Study design
This is an interventional study with a planned enrollment of 80 participants. It is testing different strengths of the Amiodarone-Infused CardiaMend patches (70mg, 150mg, and 300mg).
What's involved
You would need to be scheduled for open-chest cardiac surgery via complete median sternotomy. The patch would be applied during your surgery.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be measured from the day of your surgery up to two months or until hospital discharge, whichever comes sooner.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06730828

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

Recruiting
PHASE1Ages 20–85InterventionalPrevention
Helios Cardio Inc.
~80 participants
Updated 2024-12-12 on ClinicalTrials.gov
What's tested:The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety, defined as major adverse cardiac and cerebrovascular events (MACCE), up to subject discharge.
Measured over From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner

Conditions

Atrial Fibrillation, Postoperative

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NCT06730828

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Louisville

    Louisville, Kentuckystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mark S. Slaughter, MD · PRINCIPAL_INVESTIGATOR · University of Louisville Hospitals

Who to contact

Jaimin Trivedi, MBBS FACC
[email protected]
502-588-7638
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety, defined as major adverse cardiac and cerebrovascular events (MACCE), up to subject discharge.From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner

    MACCE is defined as in-hospital all-cause death, acute myocardial infarction (AMI), or ischemic stroke.