Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Amniotic Membrane
Brief summary
The purpose of this study is to to evaluate the rate of new onset postoperative atrial fibrillation in subjects receiving the amniotic membrane patch placed on the epicardial surface as compared to subjects who did not undergo epicardium intervention.
Detailed description
New onset postoperative atrial fibrillation (NOPAF) presents in approximately 27 to 40% of patients who have recently undergone coronary artery bypass graft (CABG) or other open heart surgeries. NOPAF can put patients at clinical risk for stroke and other arrhythmias. NOPAF commonly prolongs hospitalization leading to increased use of hospital resources, higher cost and decreased patient satisfaction. A number of risk factors have been associated with the development of NOPAF including age, prior history of atrial fibrillation, Chronic Obstructive Pulmonary Disease (COPD), chronic renal failure, diabetes and obesity. It is not entirely clear what causes NOPAF; the prevailing theory is that it is a multi-factorial process, possibly due in part to inflammation from the surgery. The usual treatments for NOPAF are associated with various side effects and risks. We propose to test the hypothesis that an amniotic membrane patch, with minimal known risk and side effects, placed on the heart's surface during surgery will reduce the incidence of NOPAF. This phase I/II prospective, single-center, randomized controlled clinical trial is being undertaken to assess the safety of the amniotic membrane patch when used in the setting of CABG surgery and whether utilization of the amniotic membrane patch to aid repair of the normal epicardium following isolated, first-time CABG procedures might result in a lower rate of NOPAF compared to subjects who did not undergo treatment with the amniotic membrane patch.
Interventions
BIOLOGICALAmniotic Membrane Patch
Sponsors
PalinGen
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * This cardiac operation is the subject's first or primary cardiac operation * The subject must be undergoing an isolated CABG procedure using a median sternotomy approach * Must have ability to provide written informed consent * Must have ability to fulfill all of the expected requirements of this clinical protocol Preoperative
Exclusion criteria
* Prior history of atrial fibrillation * Prior history of open heart surgery * Prior history of pericarditis * Prior history of anti-arrhythmia drug treatment (e.g., amiodarone, dronedarone, or sotalol) in the past six months * The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers) * Concomitant procedure planned * In the investigator's opinion, the subject may require prophylactic treatment with anti-arrhythmia drugs or temporary pacing postoperatively Intraoperative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of new onset postoperative atrial fibrillation | up to 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Procedure-related serious adverse events | up to 30 days |
Countries
United States
Outcome results
None listed