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

February 27, 2026 updated by: University of Chicago

A Prospective Study Using Intra-Pericardial Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Cardiac Arterial Bypass Grafting and/or Valve Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study involves using CardiaMend, an FDA cleared (K210331) pericardial reconstruction matrix with the addition of amiodarone, an FDA approved antiarrhythmic drug, as a prevention of post operative atrial fibrillation.

This is a single-center, prospective randomized study enrolling adult subjects undergoing isolated cardiac arterial bypass or valve surgery, via complete median sternotomy.

CardiaMend will be used according to the Instructions for Use, and then patted dry to facilitate implantation. 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. A small edge may be left open for drain placement and a small slit for the Left Internal Mammary Artery (LIMA) in case of CABG. The remaining 8 cc of amiodarone will be instilled to the closed pericardial space.

Patients will have continuous electrocardiogram (EKG) until discharge. If clinically indicated, patients will receive a monitor for home monitoring per standard of care.

Study Type

Interventional

Enrollment (Estimated)

63

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Combination product: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Atrial Fibrillation
Time Frame: Through 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.
Through discharge, an average 7 days to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Hospital Time Required Due to Atrial Fibrillation/Flutter
Time Frame: Through discharge, an average 7 days to 2 weeks
Burden of atrial fibrillation as defined by additional treatment regimen, additional time in intensive care unit (ICU), complications directly associated with atrial fibrillation
Through discharge, an average 7 days to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Helios Cardio Inc.

Investigators

  • Principal Investigator: Valluvan Jeevanandam, MD, Director of Heart and Vascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB23-0847

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Helios Cardio Inc., who will be the study collaborator will have access to only de-identified form of the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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