Preventing Postoperative Atrial Fibrillation with Amiodarone
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
This study is testing if using a heart support patch along with a heart medication during surgery can help prevent irregular heartbeats in adults having heart surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06063538 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of CardiaMend, a pericardial reconstruction matrix, combined with amiodarone, an antiarrhythmic drug, to prevent postoperative atrial fibrillation (POAF) in patients undergoing cardiac arterial bypass grafting or valve surgery. It is a single-center, prospective randomized study that enrolls adult patients scheduled for open-chest cardiac surgery. The intervention involves applying amiodarone directly to the heart during surgery, followed by the implantation of CardiaMend to support the heart's structure. Continuous electrocardiogram monitoring will be conducted until discharge to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-85 scheduled for open-chest cardiac surgery, including CABG or valve procedures, who are in sinus rhythm.
Not a fit: Patients who are not undergoing cardiac surgery or those with conditions that prevent them from providing informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative atrial fibrillation, improving recovery and outcomes for cardiac surgery patients.
How similar studies have performed: While the use of amiodarone in this context is established, the specific combination with CardiaMend is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Chicago, Illinois
- The University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Valluvan Jeevanandam, MD — Director of Heart and Vascular Center
- Study coordinator: Valluvan Jeevanandam, MD
- Email: jeevan@bsd.uchicago.edu
- Phone: 773-702-2500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.