Actively Recruiting
Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone
Led by University of Chicago · Updated on 2026-03-02
63
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
H
Helios Cardio Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing cardiac arterial bypass grafting (CABG) or valve surgery.
CONDITIONS
Official Title
Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 20 to 85 years old
- Able to provide written informed consent and willing to follow study procedures
- Scheduled for open-chest cardiac surgery via complete median sternotomy, including coronary artery bypass graft and/or valve repair or replacement, or isolated ascending aortic aneurysm repair
- Left atrial appendage procedures allowed only if combined with qualifying surgery
- In normal sinus rhythm at the time of office visit and prior EKG
You will not qualify if you...
- Unable to give voluntary written informed consent or unlikely to cooperate
- Any condition interfering with ability to comply with the study
- Participating in another interventional clinical study currently or within past 30 days
- Female who is pregnant, breastfeeding, recently pregnant within 3 months, or planning pregnancy during study
- 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, Epidermolysis bullosa, Marfan syndrome, or Osteogenesis imperfecta
- Immune-suppressed or immune-deficient (properly managed diabetes is allowed)
- Receiving systemic corticosteroid or other constant anti-inflammatory therapy
- Currently treated with amiodarone for atrial fibrillation or ventricular arrhythmias
- Disease of the left pleura, previous left pleural intervention, or chest deformity
- End-stage chronic renal disease or on dialysis
- STS risk score greater than 5.5% for 30-day mortality
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
V
Valluvan Jeevanandam, MD
CONTACT
L
Leila Yazdanbakhsh, MSCI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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