Recruiting
Early Phase 1

Amiodarone

Sponsor:

University of Chicago

Code:

NCT06063538

Conditions

Atrial Fibrillation

Post-Op Complication

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

CardiaMend in Combination with Amiodarone

Study Details

Brief summary:

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

Atrial Fibrillation

Post-Op Complication

Study ID

NCT06063538

Start date

Feb 15, 2024

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

63 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CardiaMend Pericardial and Epicardial Reconstruction Matrix used in combination with amiodarone

Patients randomized to this study arm includes the CardiaMend which will be used according to the instructions for use. It will be patted dry to facilitate implantation. Pieces will be cut to cover the right and left atria. The remaining piece will be contoured to close the anterior pericardial space. Four ampules of amiodarone (150mg/3ml; 12cc total volume) will be drawn into a syringe. 2cc will be dripped over the right atrium and a small CardiaMend patch placed to cover this area. Another 2cc will be used over the left atrium and covered with the CardiaMend. The anterior pericardial space will be closed without putting pressure on the underlying structures using the CardiaMend attached to the native pericardium utilizing running 4-0 monofilament suture.

no intervention: University of Chicago's standard of care in patients undergoing isolated CABG or valve surgery

The standard of care for this study at The University of Chicago is to ligate the left atrial appendage (LAA) during the proposed cardiac surgery (intra-operative) to reduce the occurrence of post operative atrial fibrillation (A-FIB) in combination with amiodarone injections (if applicable).

Interventions

CardiaMend in Combination with Amiodarone

The first three patient will receive 600 mg amiodarone into the intact pericardial space. Amiodarone serum levels will be tested at post operative days 2 and 6. The study will only proceed if there is a serum amiodarone level less than 25% of the normal therapeutic level. This should insure lack of systemic toxicity. After the first 3 patients have demonstrated low amiodarone blood levels, a total of up to 60 patients will be enrolled in the study.

The CardiaMend patch will saturated per the instructions and be sutured into place. Amiodarone will be dripped directly over the heart.

Primary outcome measure

  • Post Operative Atrial Fibrillation [ Time Frame: Through discharge, an average 7 days to 2 weeks ]

Central Contacts and Locations

Central contacts

Valluvan Jeevanandam, MD

773-702-2500jeevan@bsd.uchicago.edu

Leila Yazdanbakhsh, MSCI

773-834-5087leila.yazdanbakhsh@bsd.uchicago.edu

Locations

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Aaron Manewith

773-702-2500amanewith@bsd.uchicago.edu

Arijus Kavaliauskas

773-702-2500arijus.kavaliauskas@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-03-02.