Back to search results

Preventing Atrial Fibrillation After Heart Surgery with CardiaMend and Amiodarone

This study is looking at a new way to prevent an irregular heartbeat called atrial fibrillation (AFib) after open-chest heart surgery. Researchers are testing a combination of CardiaMend, a material used to rebuild the sac around the heart, and amiodarone, a medication that helps control heart rhythm. You may be eligible if you are between 20 and 85 years old, are having open-chest heart surgery like a bypass or valve repair, and can provide informed consent. The main goal is to see if this combination can reduce the number of patients who develop AFib after surgery, measured until you are discharged from the hospital (typically 7 days to 2 weeks). The study is currently recruiting 63 participants.

Study design
This is a single-center, prospective randomized study involving 63 adult participants. The study is testing a combination product of CardiaMend and amiodarone.
What's involved
You will undergo open-chest cardiac surgery where CardiaMend and amiodarone will be applied. Your heart rhythm will be continuously monitored until hospital discharge.
Compensation
Not stated in the trial record.
Follow-up
Your heart rhythm will be monitored until discharge from the hospital, which is typically 7 days to 2 weeks after surgery.

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

NCT06063538

Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone

Recruiting
EARLY_PHASE1Ages 20–85InterventionalTreatment
University of Chicago
~63 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:CardiaMend in Combination with Amiodarone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post Operative Atrial Fibrillation
Measured over Through discharge, an average 7 days to 2 weeks

Conditions

Atrial Fibrillation
Post-Op Complication

Explore related trials

Atrial Fibrillation

NCT06063538

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.

  • The University of Chicago

    Chicago, Illinoisstudy 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

  • Valluvan Jeevanandam, MD · PRINCIPAL_INVESTIGATOR · Director of Heart and Vascular Center

Who to contact

Valluvan Jeevanandam, MD
[email protected]
773-702-2500
Email the study team

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

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Post Operative Atrial FibrillationThrough discharge, an average 7 days to 2 weeks

    The patients have continuous electrocardiogram (EKG) monitoring until discharge to evaluate for any evidence of atrial fibrillation or atrial flutter which lasts longer than one hour or if less than one hour, requires medical or procedural intervention. Evidence of atrial fibrillation or atrial flutter will be confirmed by 12 lead electrocardiogram by loss or changes to the P wave, as well as irregularities in the QRS wave interval, heart rhythm, or rate. If clinically indicated, patients will receive a monitor for home monitoring per standard of care.