Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the application of hAM at the time of cardiac surgery to decrease inflammation and the subsequent substrate to reduce incidence of post-operative atrial fibrillation. Patients will randomized 1:1 to receive either hAM application or standard of care.

Official Title
-----------------
Safety and Feasibility Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation After Coronary Artery Bypass Grafting

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Biological: Human Amniotic Membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary elective CABG at the University of Utah Hospital Ability to provided informed consent and follow-up with protocol procedures Exclusion Criteria: Patients in AF at the time of surgery Prior history of sternotomy Prior history of pericarditis Currently on aggressive antiarrhythmic therapy (does not include beta blockers) Patients with an implantable cardiac device (pacemaker, ICD, CRT-D) Ejection fraction <45%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized<br> | Biological: Human Amniotic Membrane<br>* Epicardial application of human amniotic membrane during cardiac surgery<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment of the use of human amniotic membrane during cardiac surgery by incidence of adverse events | The AM applied epicardially will be assessed for signs of hyperacute rejection i.e. membrane changing color; cardiac tamponade or constriction assessed by echocardiogram and transmission of infectious diseases. The incidence of adverse events (AEs) will be reported as percentages, with two-sided 95% confidence intervals. Statistical comparisons of AEs between the AM treatment and the control group will be made using a chi-square, or Fisher's exact test, as appropriate (based on the minimum expected cell frequencies). | 1 month | 
| Comparison of the incidence of Post Op Atrial Fibrillation between patients who receive hAM and controls | The incidence of Post Op Atrial Fibrillation will be compared between the treatment and control group using mobile telemetry. This comparison will be analyzed using chi-square or Fisher's exact test as appropriate. | 1 month | 
| Comparison of inflammatory response (systemic and pericardial) between patients who received hAM and controls | The proinflammatory response to cardiopulmonary bypass circuit as measured by numerous systemic and pericardial inflammatory markers i.e. C-reactive protein (CRP), TNF-α, Interleukin (IL)-6 and brain natriuretic peptide (BNP), have been linked to induction of atrial fibrillation. We will collect pericardial (from chest tubes) and systemic fluid markers at pre-specified intervals. We will assess the percentage change in the levels of the biomarkers as compared to their pre-operative baseline, as there will be expected variability in the level of these biomarkers at baseline. | 1 month |