Actively Recruiting
Use of Amiodarone-Infused CardiaMend Patches to Prevent New-Onset Postoperative Atrial Fibrillation in Cardiac Surgery Patients
Led by Helios Cardio Inc. · Updated on 2024-12-12
80
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a new way to deliver amiodarone, a drug commonly used in heart surgery, by placing a patch containing the drug directly on the heart instead of through an intravenous line. The study focuses on patients aged 20 to 85 undergoing open chest cardiac surgery and aims to determine if the patch is safe and if it can reduce the rate of irregular heart rhythms called postoperative atrial fibrillation (POAF) after surgery. The treatment is not yet approved by the FDA and involves careful monitoring to assess heart rhythm changes. Participants will be randomly assigned to one of four groups: a control group receiving standard care with no patch, or one of three groups receiving low (70 mg), medium (150 mg), or high (300 mg) doses of the amiodarone-infused CardiaMend patches. Each participant in the patch groups will have three patches applied to specific areas on the heart during surgery. The patches are designed to deliver the drug directly to the heart's surface to potentially prevent POAF. Throughout the study, participants will be closely monitored by doctors and research staff. They will have blood tests, electrocardiograms (EKGs), and echocardiograms to check heart function. Participants will be trained to use a portable EKG recorder at home approximately 30 days and six months after surgery. Follow-up visits will occur at these times to assess heart rhythm and overall health. Total participation will last about seven months, during which safety and heart rhythm outcomes will be carefully recorded and analyzed.
CONDITIONS
Brief 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 aged 20 to 85 years
- Able to give voluntary written informed consent and willing to comply with study procedures
- Scheduled for open-chest cardiac surgery via complete median sternotomy
- In normal 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 legally incompetent
- Conditions interfering with study compliance
- Participating in another interventional clinical study or participated in last 30 days
- Pregnant, breastfeeding, recently pregnant within 3 months, or planning pregnancy
- Active skin or deep infection at implantation site
- History of chronic wounds or wound-healing disorders
- Known connective tissue diseases such as Ehlers-Danlos syndrome, Marfan syndrome, Osteogenesis imperfecta
- Immune-suppressed or immune deficiency (except well-managed diabetes)
- On systemic corticosteroids or constant anti-inflammatory therapies
- On medications known to interact with amiodarone or causing QT prolongation
- Have implantable cardiac devices (CRTs, ICDs, pacemakers)
- History of atrial fibrillation or ablation for atrial fibrillation
- Currently receiving amiodarone for atrial fibrillation or ventricular arrhythmias
- Disease of left pleura, previous left pleural intervention, or chest deformity
- Heart failure with BNP >1000, low ejection fraction <35%, end-stage renal disease or dialysis
- Electing to receive an ablative procedure for atrial fibrillation during surgery
- Previous cardiac surgery via sternotomy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of the surgery
Participants undergo open chest cardiac surgery where the amiodarone-infused CardiaMend patches may be applied to the surface of the heart during the operation.
1 surgical procedure visit
Duration - Up to 2 months or until hospital discharge, whichever is sooner
Participants are monitored during the hospital stay and up to two months post-surgery for safety outcomes, including heart rhythm and patch migration, as well as hospital readmissions.
Multiple visits during hospital stay and follow-up visits up to 2 months post-surgery
Duration - Up to 30 days post hospital discharge
Participants are followed for hospital readmission and medication use related to heart rhythm management up to 30 days after hospital discharge.
1 to 2 visits depending on recovery
Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
J
Jaimin Trivedi, MBBS FACC
C
Chief Operating Officer, Helios Cardio Inc., PhD
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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