Intrapericardial Amiodarone for the Prevention of Postoperative Atrial Fibrillation.
Louay M Habbab, F Victor Chu
https://pubmed.ncbi.nlm.nih.gov/26833498Actively Recruiting
Early Phase 1
Age: 20Years - 85Years
All Genders
ID06063538
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
Led by University of Chicago · Updated on 2026-03-02
63
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the use of CardiaMend combined with amiodarone to prevent postoperative atrial fibrillation (POAF) in adults undergoing cardiac arterial bypass grafting (CABG) or valve surgery. This prospective randomized study focuses on patients having open-chest surgery via median sternotomy and aims to reduce the occurrence of POAF, a common complication after such surgeries. The study involves applying CardiaMend, a pericardial reconstruction matrix, over the right and left atria after drizzling amiodarone directly onto these areas. The anterior pericardial space is then closed using CardiaMend without pressure on underlying structures. Amiodarone is instilled into the pericardial space to help prevent arrhythmias. The control group receives the University of Chicago's standard care, which includes ligation of the left atrial appendage during surgery and amiodarone injections as applicable. Participants will have continuous electrocardiogram monitoring until hospital discharge, usually lasting about 7 days to 2 weeks. If needed, home monitoring may be provided. Researchers will measure the occurrence of postoperative atrial fibrillation and additional hospital time required due to atrial fibrillation or flutter. The total study participation will last through discharge with ongoing evaluation of amiodarone blood levels in the initial patients to ensure safety.
CONDITIONS
Brief Title
Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone
Who Can Participate
Age: 20Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 20 to 85 years
- Able to provide written informed consent and willing to comply with study procedures
- Scheduled for open-chest cardiac surgery via complete median sternotomy, including coronary artery bypass graft and/or valve repair or replacement
- In sinus rhythm at the time of office visit and prior electrocardiogram
- Left atrial appendage procedures allowed only if combined with qualifying cardiac surgery
You will not qualify if you...
- Unable to give voluntary written informed consent or unlikely to cooperate
- Participating in another interventional clinical study currently or within the last 30 days
- Pregnant, breastfeeding, recently pregnant in last 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 or Marfan syndrome
- Immune-suppressed or immune-deficiency conditions (except well-managed diabetes)
- On systemic corticosteroid or other constant anti-inflammatory therapies
- Currently receiving amiodarone treatment for atrial fibrillation or ventricular arrhythmias
- Disease or prior intervention involving the left pleura or chest deformity
- End-stage chronic renal disease or on dialysis
- Society of Thoracic Surgeons risk score greater than 5.5% for 30-day mortality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day and hospital stay until discharge (approximately 7 days to 2 weeks)
Participants undergo cardiac arterial bypass grafting and/or valve surgery with implantation of the CardiaMend patch combined with amiodarone to prevent post-operative atrial fibrillation. Amiodarone is applied directly to the heart during surgery.
Continuous electrocardiogram (EKG) monitoring until discharge
Post-operative Follow-up
Duration - Up to 2 weeks post discharge
Participants are monitored after discharge with home monitoring if clinically indicated to assess heart rhythm and detect atrial fibrillation.
Follow-up visits as needed based on clinical indication
Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Loading map...
Research Team
V
Valluvan Jeevanandam, MD
L
Leila Yazdanbakhsh, MSCI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Safety considerations in the pharmacological management of atrial fibrillation.
A John Camm
https://pubmed.ncbi.nlm.nih.gov/181914702014 AATS guidelines for the prevention and management of perioperative atrial fibrillation and flutter for thoracic surgical procedures.
Gyorgy Frendl, Alissa C Sodickson, Mina K Chung...
https://pubmed.ncbi.nlm.nih.gov/25129609Topical amiodarone to prevent postoperative atrial fibrillation: Need for further study.
Jordan Beau, Alexander Kulik
https://pubmed.ncbi.nlm.nih.gov/26806512Extracellular acidification reveals the antiarrhythmic properties of amiodarone related to late sodium current-induced atrial arrhythmia.
Michael Ramon de Lima Conceição, Jorge Lucas Teixeira-Fonseca, Leisiane Pereira Marques...
https://pubmed.ncbi.nlm.nih.gov/38619735Prevention of postoperative atrial fibrillation in cardiac surgery: a quality improvement project.
Sinead Egan, Coilin Collins-Smyth, Shruti Chitnis...
https://pubmed.ncbi.nlm.nih.gov/37919634Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation.
Jonathan P Piccini, Anders Ahlsson, Paul Dorian...
https://pubmed.ncbi.nlm.nih.gov/38661602Mechanisms, prevention, and treatment of atrial fibrillation after cardiac surgery.
Najmeddine Echahidi, Philippe Pibarot, Gilles O'Hara...
https://pubmed.ncbi.nlm.nih.gov/18294562Incidence of postoperative atrial fibrillation recurrence in patients discharged in sinus rhythm after cardiac surgery: a systematic review and meta-analysis.
Nicole Lowres, Georgina Mulcahy, Kai Jin...
https://pubmed.ncbi.nlm.nih.gov/29161419Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions.
Alfredo Rego, Patricia C Cheung, William J Harris...
https://pubmed.ncbi.nlm.nih.gov/30876459