Amiodarone for Preventing Atrial Fibrillation After Surgery
Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone
Recruiting
Early Phase 1Interventional Study
Atrial FibrillationPost-Op Complication
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 – 85
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
63 (estimated)
Sponsor
University of Chicago · Other
Who this trial is looking for
This trial is looking for patients aged 20 to 85 who are scheduled for heart surgery. Participants will receive a treatment to help prevent a common heart rhythm problem after their surgery.
Are You a Good Fit for This Trial?
Must not be takingAmiodarone
You may be able to join if
I am aged 20 to 85 years old.
I can understand and sign a consent form for the study.
I am having open-chest heart surgery.
I am in sinus rhythm at my last doctor visit.
You may not be able to join if
I cannot give my consent voluntarily.
I have an infection at the surgery site.
I am pregnant, breastfeeding, or planning to become pregnant.
I have a history of chronic wounds.
I have a known connective tissue disease.
I am immune-suppressed.
I am receiving certain anti-inflammatory treatments.
I have end-stage chronic kidney disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Subject aged 20-85 years old.
* Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures.
* Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes:
* Coronary…
Inclusion Criteria:
* Subject aged 20-85 years old.
* Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures.
* Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes:
* Coronary artery bypass graft (CABG) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid)
* Isolated ascending aortic aneurysm replacement/repair
* Note: Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own.
* In sinus rhythm at the time of office visit and prior electrocardiogram (EKG) (note: continuous EKG monitoring for 48 hours is not required).
Exclusion Criteria:
* Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with, testing center or investigator.
* Any condition which could interfere with the subject's ability to comply with the study.
* Ongoing participation in an interventional clinical study or 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 course of the study.
* Active skin or deep infection at the site of implantation.
* History of chronic wounds or wound-healing disorders.
* Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
* Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion).
* Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
* Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
* Disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
* Subjects with end-stage chronic-renal disease / dialysis.
* STS (Society of Thoracic Surgeons Score) risk score \>5.5% for 30 day mortality.
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